KFEB
| Elnök: | Dr. Bitter István |
| Alelnök: | Dr. Fürst Zsuzsanna |
| Titkárok: | Dr. Arányi Péter Dr. Reusz György |
| Titkárság: | Jegesi Bernadett Kovács Csaba Antalné Edit Baski Barnabás |
| Székhely címe: | 1054 Budapest, Báthory u. 10. |
| Levelezési cím: | Belügyminisztérium, 1903 Budapest, Pf.: 314 |
| Telefon: | (+36 1) 795-4873 (+36 1) 795-1195 (+36 1) 795-6549 |
| E-mail: | kfebtitkarsag@bm.gov.hu |
| SUSAR beküldéséhez: | safetyreport@bm.gov.hu |
| Tárgyalt kérelmek 2024-ben: |
Új vizsgálat: 555 darab Módosítás: 1754 darab |
A Bizottság tagjai
| Elnök: | Dr. Bitter István pszichiáter, neurológus, klinikai farmakológus |
| Alelnök: | Dr. Fürst Zsuzsanna farmakológus, klinikai farmakológus |
| Titkárok: | Dr. Arányi Péter biokémikus Dr. Reusz György csecsemő- és gyermekgyógyász, nefrológus, hipertonológus |
| Tagok: | Dr. Blaskó György belgyógyász, klinikai farmakológus, gasztroenterológus Dr. Borsodi Anna biokémikus Dr. Czobor Pál biológus, klinikai biostatisztikus Dr. Dobó István sebész Dr. Egri László kézsebész, traumatológus, teológus Dr. Farsang Csaba belgyógyász, nefrológus, hipertonológus, klinikai farmakológus Dr. Gyurkovits Kálmán csecsemő- és gyermekgyógyász, gyermektüdőgyógyász, klinikai farmakológus, gasztroenterológus Dr. Herold Róbert pszichiáter Dr. Hunyady Béla belgyógyász, gasztroenterológus, klinikai farmakológus Dr. Hunyadi János bőrgyógyász, allergológus, klinikai immunológus Dr. Kiss Róbert Gábor kardiológus, belgyógyász Dr. Ludwig Endre infektológus, belgyógyász, klinikai farmakológus Dr. Mangel László Csaba pszichiáter, klinikai onkológus, radioterapeuta Dr. Maráz Anikó sugárterapeuta, klinikai onkológus, klinikai farmakológus Dr. Nagy Ágnes hematológus, belgyógyász Dr. Nagy Zsuzsanna belgyógyász, klinikai onkológus Dr. Orodán Mária jogász Dr. Orosz Gábor Béla teológus, lelkész Dr. Póka Róbert nőgyógyász, klinikai onkológus Dr. Réthelyi János pszichiáter, klinikai genetikus Dr. Rosta András onkológus, hematológus, belgyógyász Dr. Sipos Ildikó neurológus Dr. Szaleczky Erika onkológus, hematológus, belgyógyász Szántai Anita speciális pedagógia szaktanár Dr. Szűcs Nikolette endokrinológus, belgyógyász Dr. Tarnai Julianna reumatológus, klinikai farmakológus |
| Állandó meghívottak: | Dr. Hajdú Ágnes Zita NNGYK |
A Külső Szakértői Bizottság tagjai
Dr. Bereczki Dániel neurológus, pszichiáter
Dr. Borvendég János belgyógyász, klinikai farmakológus
Dr. Csiba László neurológus, pszichiáter
Dr. Demetrovics Zsolt alkalmazott egészségpszichológiai szakpszichológus
Dr. Fülesdi Béla neurológus, aneszteziológus
Dr. Gera István fogorvos, parodontológus
Dr. Hornyák Lajos belgyógyász, onkológus, klinikai farmakológus
Dr. Járay Zoltán belgyógyász, kardiológus, klinikai farmakológus
Dr. Julesz János belgyógyász, endokrinológus
Dr. Kemény Lajos bőrgyógyász, allergológus
Dr. Kiss Emese Virág reumatológus, belgyógyász, allergológus-klinikai immunológus
Dr. Komoly Sámuel neurológus
Dr. Mészner Zsófia csecsemő- és gyermekgyógyász, infektológus
Dr. Molnár Márk neurológus, pszichofiziológus
Dr. Nagy Zoltán Zsolt szemész
Dr. Németh Gábor szemész
Dr. Németh Péter immunológus
Dr. Ostoros Gyula onkológus
Dr. Péley Bernadette pszichológus
Dr. Prinz Gyula belgyógyász, infektológus
Dr. Sallay Péter gyermekgyógyász, nefrológus
Dr. Sebeszta Miklós belgyógyász, kardiológus
Dr. Somogyi Anikó belgyógyász, klinikai farmakológus, endokrinológus
Dr. Süveges Ildikó szemész
Dr. Szekanecz Zoltán reumatológus, belgyógyász, immunológus
Dr. Szijártó Attila sebész
Tamásné Dr. Németh Ágnes gyógyszerhatástan szakgyógyszerész
Dr. Tenke Péter urológus
Dr. Tóth Judit jogász
Dr. Vértes András kardiológus
Dr. Vidnyánszky Zoltán biológus
Módszertani levelek
– BETEGKÁRTYA szakmai-etikai követelmények (2015.12.15.)
TEMPLATES:
Investigator Curriculum Vitae (2023.03.)
Site Suitability Form – current version, valid until January 1, 2026 (2023.10.)
Site Suitability Form – to be used from January 2, 2026 (2025.11.)
Ajánlások klinikai gyógyszervizsgálatot kezdeményezőknek
A bioszimiláris igazolására tervezett klinikai gyógyszervizsgálatok szakmai-etikai értékelése (2022.11.28.)
Ajánlás a klinikai vizsgálatok betegtájékoztatóinak adatvédelmi követelményeiről a GDPR kapcsán (2023.03.14.)
TEMPLATES:
Investigator Curriculum Vitae (2023.03.)
Site Suitability Form – current version, valid until January 1, 2026 (2023.10.)
Site Suitability Form – to be used from January 2, 2026 (2025.11.)
Tájékoztatás a Gyógyszerrendelet alapján beadandó vizsgálati kérelmek benyújtóinak
National requirements for initial submissions / substatnital modifications
Originális vizsgálati kérelmekre és lényeges módosításokra vonatkozó nemzeti követelmények
The list of required documentation and information is set out in Annex I. of REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.
In particular:
The application dossier for an application limited to Part I of the assessment report referred to in Article 11 shall be limited to sections B to J and Q of Annex I.
National requirements related to Part I:
Protocol synopsis in Hungarian language preferably a certified translation of the original protocol synopsis (not to be confused with trial summary for lay people);
The application dossier for an application limited to Part II of the assessment report referred to in Article 11 and the application dossier for an application referred to in Article 14 shall be limited to sections K to R of Annex I.
National requirements related to Part II of the application dossier in particular include
CV of PIs and co-investigators according to the templates proposed by CTEG as modified for Hungary and available on our homepage;
Site suitability templates according to the templates proposed by CTEG as modified for Hungary and available on our homepage;
Patient emergency card as addenda to the (main) ICF according to the specifications available on our homepage;
All recruitment material in their final forms in Hungarian language;
Protocol signature pages signed by PIs and Co-investigators;
A list in Hungarian language of Part II documents submitted in order to help the lay members of the Ethics Committee for Clinical Pharmacology to evaluate the submission.
In case both Part I and Part II application dossiers are submitted at the same time, all documents listed above should be provided for evaluation.
List of modified documents (including all newly created documents, e.g. templates for new PI/new site etc.) should be included in the cover letter in Hungarian language in case of substantial modifications. For accurate identification of new and/or updated documents, their version number and date of issue must also be provided. New documents must be submitted in both clean and change tracking formats. Conformity to all requirements will be thoroughly checked for applications submitted after 01.07.2023.
AZ ENGEDÉLY IRÁNTI KÉRELEMHEZ SZÜKSÉGES DOKUMENTÁCIÓ AZ EURÓPAI PARLAMENT ÉS A TANÁCS 536/2014/EU RENDELETE (2014. április 16.) az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatairól és a 2001/20/EK irányelv hatályon kívül helyezéséről I. Melléklete szerint.
Részletezve:
Az értékelő jelentés I. részében szereplő szempontokra korlátozódó engedélyezéshez szükséges dokumentáció I. Melléklet B–J. és Q. szakaszára korlátozódik.
Az értékelő jelentés I. részéhez kapcsolódó magyar tagállami követelmény:
Magyar nyelvű protokoll szinopszis az eredeti protocol synopsis lehetőleg hivatalos fordítása, nem tévesztendő össze a laikusok számára készített vizsgálati összefoglalóval
Az értékelő jelentés II. részében szereplő szempontokra korlátozódó engedélyezéshez szükséges dokumentáció az I. Melléklet K–R. szakaszára korlátozódik.
Az értékelő jelentés II. részéhez kapcsolódó magyar tagállami követelmények:
A vizsgálatvezetők és a társvizsgálók szakmai önéletrajzai a honlapunkon megtalálható, a Magyarországi kívánalmakhoz igazított CTEG templát szerint;
A vizsgálatvezetők és a társvizsgálók által aláírt protocol signature oldalalak;
A vizsgálóhelyek megfelelőségét igazoló dokumentumok, a honlapunkon megtalálható, a Magyarországi kívánalmakhoz igazított CTEG templát szerint;
A fő tájékozott belegyezési dokumentum mellékleteként felcsatolt betegkártya, a honlapunkon található kívánalmaknak megfelelően elkészítve;
Minden toborzó dokumentum végleges formában, magyar nyelven;
Az értékelő jelentés II. részéhez benyújtott dokumentumok listája, melynek célja a KFEB nem orvos tagjai számára történő segítségnyújtás a beterjesztett dokumentumok értékeléséhez.
Amennyiben a vizsgálati kérelem I. és a II. részét egyidejűleg nyújtják be, minden fent felsorolt dokumentumot egyszerre kell a Bizottság rendelkezésére bocsájtani.
A lényeges módosítási kérelmek estében feltétlenül szükséges a módosított dokumentumok (beleértve az új dokumentumokat, pl. új vizsgálóhely/vizsgálatvezető stb. adatait) felsorolása a magyar nyelvű kísérőlevélben. Az új, illetve frissített dokumentumok pontos azonosítása céljából azok verziószámát és kiadásuk dátumát is meg kell adni. Az új dokumentumokat tiszta és változás követő formában is be kell nyújtani.
A fenti követelményeknek való megfelelést a Bizottság szigorúan ellenőrizni fogja a 2023.07.01. után benyújtott kérelmek esetében.
TEMPLATES:
Investigator Curriculum Vitae (2023.03.)
Site Suitability Form – current version, valid until January 1, 2026 (2023.10.)
Site Suitability Form – to be used from January 2, 2026 (2025.11.)
Part II kérelmek értékelésére vonatkozó kérdések és válaszok
Q1: Melyek az ETT KFEB tevékenységét meghatározó legfontosabb jogszabályok?
A1: Felhívjuk a benyújtók figyelmét a következő jogszabályokban foglaltakra:
• Az egészségügyről szóló 1997. évi CLIV. törvény (Egészségügyi törvény) (különösen a VIII. és IX. fejezete)
• Az emberi alkalmazásra kerülő gyógyszerekről és egyéb, a gyógyszerpiacot szabályozó törvények módosításáról szóló 2005. évi XCV. törvény (Gyógyszertörvény)
• A humángenetikai adatok védelméről, a humángenetikai vizsgálatok és kutatások, valamint a biobankok működésének szabályairól szóló 2008. évi XXI. törvény (Genetikai törvény)
• Az emberi felhasználásra szánt gyógyszerek klinikai vizsgálatairól és a 2001/20/EK irányelv hatályon kívül helyezéséről szóló, 2014. április 16-i 536/2014/EU európai parlamenti és tanácsi rendelet (CTR)
• A természetes személyeknek a személyes adatok kezelése tekintetében történő védelméről és az ilyen adatok szabad áramlásáról, valamint a 95/46/EK rendelet hatályon kívül helyezéséről (általános adatvédelmi rendelet) szóló, 2016. április 27-i (EU) 2016/679 európai parlamenti és tanácsi rendelet (GDPR)
• Az információs önrendelkezési jogról és az információszabadságról szóló 2011. évi CXII. törvény
• Az egészségügyi és a hozzájuk kapcsolódó személyes adatok kezeléséről és védelméről szóló 1997. évi XLVII. törvény
Fentieken túlmenően az ETT KFEB honlapján található információk ismerete segíti a benyújtott kérelmek gyors elfogadását.
Q2: Mi lehet az ICF címe és hány dokumentumból kell állnia?
A2: Tájékoztatáson alapuló beleegyező nyilatkozat, egyetlen dokumentum. Kivételt képez(nek) a genetikai tájékoztató(k), és beleegyező nyilatkozat(ok), amely(ek)nek különálló dokumentum(ok)nak kell lenniük a Genetikai törvény előírásai miatt. Minden dokumentumhoz egyetlen aláírás sorozat tartozik. Amennyiben a dokumentum címzettje nem tud írni/olvasni és ezért szóban ismertetik vele a dokumentumot, illetve szóban adja a beleegyezését, úgy két tanúnak is alá kell írnia a dokumentumot. A tanúknak meg kell adni a lakcímét (elérhetőségét) is.
Q3: Mit kell tartalmaznia a Tájékoztatáson alapuló Beleegyező nyilatkozatnak?
A3: A vonatkozó jogszabályok és az ETT KFEB döntési gyakorlatának megfelelően a Tájékoztatáson alapuló Beleegyező nyilatkozatnak a következőket kell tartalmaznia:
1. a klinikai vizsgálat azonosító adatait (EUCT szám, protokollszám és a vizsgálat címe is fontos),
2. annak az egészségügyi szolgáltatónak a megnevezését, ahol a klinikai vizsgálatot végezni kívánják,
3. a klinikai vizsgálat vezetőjének, illetve a tájékoztatást végző személynek a nevét, beosztását, munkaköre megnevezését,
4. a vizsgálati alany személyazonosító adatait (nevét, születési helyét és idejét), korlátozottan cselekvőképes kiskorú és cselekvőképességében az egészségügyi ellátással összefüggő jogok gyakorlása tekintetében részlegesen korlátozott vagy cselekvőképtelen vizsgálati alany esetén az Eütv. 16. §-a szerinti nyilatkozattételre jogosult személy (a továbbiakban: nyilatkozattételre jogosult személy) azonosító adatait is,
Ugyanakkor a beteg vizsgálati kódszámát nem tartalmazhatja a dokumentum.
5. a betegkártya kiállításáról szóló tájékoztatást,
6. a betegkártyán szerepelő adatokat, ezek kezelésére vonatkozó szabályokat,
7. az arra vonatkozó figyelemfelhívást, hogy a vizsgálati alany a betegkártyát saját érdekében a vizsgálat során mindig tartsa magánál,
8. tájékoztatást arra vonatkozóan, hogy a betegkártyán a vizsgálati alany neve és kódszáma csak betegbiztonsági okból szerepelhet együtt,
9. a vizsgálati alany adatainak kezelésére, az azokhoz való hozzáférésére vonatkozó szabályokat,
10. a klinikai vizsgálat kutatási jellegére való utalást, a klinikai vizsgálat célját, várható időtartamát, a bevonni kívánt személyek számát, a klinikai vizsgálat menetét, a tervezett beavatkozások jellegét, gyakoriságát,
11. a vizsgálati alany rendelkezésére álló egyéb, elfogadott kezelési lehetőségeket, valamint tájékoztatást arra vonatkozóan, hogy a klinikai vizsgálat a már megkezdett kezelésének megszakítását jelentheti, és a megkezdett kezelés megszakításának milyen következményei lehetnek a vizsgálati alany számára,
12. a lehetséges és a várható következmények, kockázatok és kellemetlenségek részletes leírását, valamint az arra való utalást, hogy a klinikai vizsgálat során olyan nemkívánatos események is felléphetnek, amelyek előre nem láthatóak,
13. az ésszerűen várható előnyök leírását, vagy ha a vizsgálati alany számára előny a klinikai vizsgálatból nem várható, ennek a ténynek a közlését,
14. placebo alkalmazásakor részletes tájékoztatást a placebo alkalmazásának lényegéről és arról, hogy a vizsgálati alany milyen valószínűséggel kerülhet placebo csoportba,
15. a vizsgálati gyógyszer rövid hatástani ismertetését,
16. azt, hogy a vizsgálat befejezése után a vizsgálati alany – amennyiben szükséges – milyen további egészségügyi ellátásban részesül,
17. arra vonatkozó figyelemfelhívást, hogy a vizsgálati alany – korlátozottan cselekvőképes kiskorú és cselekvőképességében az egészségügyi ellátással összefüggő jogok gyakorlása tekintetében részlegesen korlátozott vagy cselekvőképtelen vizsgálati alany esetén a nyilatkozattételre jogosult személy – a klinikai vizsgálatban történő részvételre vonatkozó beleegyezése önkéntes és befolyásolástól mentes, az bármikor akár szóban, akár írásban indokolás nélkül visszavonható anélkül, hogy ebből a vizsgálati alanynak hátránya származna,
18. a vizsgálati alany számára a klinikai vizsgálattal összefüggő kár bekövetkezése, illetve személyiségi jog megsértése esetén nyújtandó kezelésre, kár megtérítésére, illetve sérelemdíj megfizetésére és kártalanításra [GyT. 21. § (1) bekezdés] és az ezek igénybevételének módjára vonatkozó tájékoztatást, továbbá annak a személynek és szervezetnek a nevét és magyarországi elérhetőségét, akihez vagy amelyhez a vizsgálati alany a kár bekövetkezésekor fordulhat. Az egészségkárosodással kapcsolatos tájékoztatásnak ki kell térnie a kártérítésre, kártalanításra és sérelemdíjra is. A vizsgálat alanyát teljeskörű sérelemdíj és teljeskörű kártérítés illeti meg (2005. évi XCV. Gyógyszertörvény 21.§ (1) bekezdés). Amennyiben a vizsgálati alany egészségkárosodást szenved, az engedélyező hatóság által jóváhagyott terv szerint végzett vizsgálat esetén, akkor a kezelésének a költségeit a Szponzor (Megbízó), illetve annak biztosítója fedezi a Gyógyszertörvény 21§ (1) bekezdés a) pontja, és a Gyógyszertörvény 3.§ (4) bekezdése alapján. Az egészségkárosodást szenvedett vizsgálati alanynak az eseményt a felelősség vélelmezése nélkül a vizsgálatvezető és a betegtájékoztatóban megadott biztosító felé a lehető leghamarabb jeleznie kell.
19. a GyT. 3. § (4) bekezdése szerinti felelősségbiztosításban szereplő biztosító megnevezését, magyarországi elérhetőségét és kapcsolattartási adatait, ideértve a biztosító kapcsolattartójának megnevezését és telefonszámát.
20. a vizsgálati alany számára járó költségtérítést, ha van ilyen, kiemelve, hogy csak igazolt költségeket lehet megtéríteni. Pontosan fel kell sorolni, hogy melyek azok a költség típusok, amelyeket a szponzor meg kíván téríteni. A példálózó megfogalmazás, vagy feltételes mód használata („megtérítheti”) nem megfelelő. Amennyiben a költségtérítésben a szponzor külső szolgáltatót vesz igénybe, a szolgáltató és a beteg közötti szerződés lényeges elemeit, különös tekintettel az adatvédelmi kérdésekre és az esetleges szolgáltatói díjakra, a betegtájékoztató dokumentumnak tartalmaznia kell és azokba a betegnek bele kell egyeznie. Amennyiben a költségtérítés a szponzortól független szolgáltató segítségével történik, fel kell sorolni, hogy a szolgáltató számára milyen adatokat ad át a vizsgálóhely. Ha az adatokat közvetlenül a beteg adja át a szolgáltatónak egy szerződésnek megfelelően, amelyet a beteg a szolgáltatóval köt, akkor ennek a szerződésnek a lényeges tartalmi elmeit a fel kell tüntetni a Tájékoztatáson alapuló Beleegyező nyilatkozatban.
21. a tájékoztatáson alapuló beleegyező nyilatkozat aláírásának dátumát,
22. a klinikai vizsgálat vezetőjének vagy a tájékoztatást adónak az aláírását,
23. a tájékoztatáson alapuló beleegyező nyilatkozatot tevő aláírását.
Q4: Milyen tájékoztatást kell tartalmaznia a Tájékoztatáson alapuló beleegyező nyilatkozatnak a vizsgálati alany személyes adatainak a kezelésére vonatkozóan?
A4:
1. Az adatvédelmi tájékoztatóban egyértelműnek kell lennie, hogy az adatkezelő személyes adatokat, kódolt vagy anonim adatokat kezel, és ezt következetesen kell alkalmazni az adatvédelmi tájékoztatóban. Kerülni kell a pontatlan, nem egyértelmű, illetve a felelősség elhárítását szolgáló kijelentéseket, mint pl. „valószínűleg”, „előfordulhat” vagy, hogy „nem tudja a megbízó a személyes adatok védelmét biztosítani”. A kezelt adatokat tételesen fel kell sorolni. A gyűjteni kívánt adatok között nem szerepelhet a „faji hovatartozás” megjelölés, helyette az „etnikai hovatartozás” fogadható el. Nem gyűjthetők a szexuális életre vonatkozó adatok, eltekintve a különleges, orvos szakmai indokoltságú esetektől.
2. A tájékoztatóban egyértelműen szerepelnie kell annak, hogy a vizsgálóhelyről a vizsgálati alanyok személyes és különleges adatai (így például az egészségügyi adatok vagy az etnikai származásra vonatkozó adat) csak kódolt vagy anonimizált formában továbbíthatók, továbbá, hogy kódolt adat esetén a kódkulcs nem továbbítható. Kivételes és a beteg érdekei alapján indokolt esetben együtt szerepelhetnek a beteg születési adatai és neve a vizsgálati kódszámával. Az adatokhoz való hozzáférés körében az adatvédelmi tájékoztatóban fel kell sorolni a betekintési, illetve hozzáférési joggal rendelkező személyeket, és kijelenteni, hogy ők is csak a vizsgálóhelyen tekinthetnek bele ezen adatokba, és az adatokról nem készíthetnek másolatot.
3. Ki kell térni az adattovábbítás tényére, az adattovábbítás és különösen a harmadik országba való adattovábbítás garanciáira, a címzettek pontos megnevezésére, valamint meg kell nevezni az adatkezelés körülményeit: az adatokat hogyan kódolják, mennyi ideig és hol tárolják, és ezeket hogyan használják fel a vizsgálattal kapcsolatban. Az adatok másodlagos felhasználása esetén (amennyiben nem anonim adatokról van szó, és az elsődleges felhasználáskor nem tájékoztatták a vizsgálati alanyt az adat további felhasználásának céljáról) a vizsgálati alany újbóli beleegyezése szükséges. Ezeket a követelményeket az olyan vizsgálatokra is alkalmazni kell, amikor pl. vér, illetve szövetminta vételére kerül sor a vizsgálat/alvizsgálat folyamán. Ezek vonatkoznak genetikai adatok továbbítására is. Ilyen esetekben a Genetikai törvényre mindenképp hivatkozni kell!
4. Az adatkezelési tájékoztatónak feltétlenül tartalmaznia kell az adatkezelés célját és az adatkezelés jogalapját, ami a klinikai gyógyszervizsgálatok esetében csak az érintett hozzájárulása lehet.
5. A vizsgálati alanyt tájékoztatni kell arról, hogy ha a rá vonatkozó adatkezelés során jogai sérülnek, akkor Magyarországon kihez fordulhat jogai érvényesítése érdekében, továbbá meg kell adni a Nemzeti Adatvédelmi és Információszabadság Hatóság (NAIH) postai címét és internetes elérhetőségét is.
Q5: Be kell nyújtani a Betegkártyát a Part II engedélyeztetési dokumentumai között?
A5: Igen. A Betegkártyát magyar nyelven, végleges formájában kell benyújtani. A CTIS-ben célszerűen az L2 dokumentumok között lehet benyújtani a betegkártyát.
Q6: Mit kell tartalmaznia a betegkártyának?
A6: A betegkártyán feltétlenül szerepeljen
1. a vizsgálatban résztvevő beteg neve, születési ideje,
2. a vizsgálat címe (protokoll száma),
3. a vizsgálati gyógyszer megnevezése, továbbá a vizsgálati gyógyszer hatásmódja (például kináz gátló, monoklonális ellenanyag stb.), amennyiben az elnevezésből ez nem derül ki,
4. a vizsgálatban szereplő indikációja,
5. ellenjavallata,
6. veszélyes interakciók,
7. a vizsgálóhely címe,
8. a vizsgálatot vezető orvos (vagy egy általa megjelölt másik orvos) neve, 24 órán át elérhető telefonszáma,
9. minden egyéb szükségesnek tartott információ, például a vizsgálatban alkalmazott szerek esetlegesen sürgősségi beavatkozást indokló mellékhatásai.
Q7: Milyen egyéb dokumentumokat kell még benyújtani a vizsgálati kérelem Part II részének magyarországi engedélyeztetéséhez, illetve meglévő engedély lényeges módosítási kérelméhez?
A7: A CTR Annex 1 K-R fejezeteiben felsoroltakon kívül be kell nyújtani
1. egy magyar nyelvű kísérőlevelet, mely pontos listát tartalmaz az engedélyeztetni kívánt dokumentumok megnevezésével, beleértve azok verziószámát és kibocsátási dátumát is,
2. a betegkártyát,
3. a vizsgálatvezetők által aláírt protokoll elfogadási nyilatkozatokat.
Q8: Kell-e ügyelni a nyelvhelyességre?
A8: Igen. Tekintettel arra, hogy az alapdokumentumok általában angol nyelven készülnek, a szó szerinti fordítás sok esetben egyenetlen színvonalú és sokszor zavaró a nem megfelelő igeragozás (pl. tegező/magázó formák keveredése). A nyelvi lektorálás hiánya néha értelemzavaró hibákhoz vezet. Magyarországon nem érvényes, pl. USA-beli jogszabályokra történő hivatkozás helyett a megfelelő magyar jogszabályokat kell idézni. Mindezen hibák kijavítását a Bizottság általában hiánypótlási felszólítás formájában kéri, ami az eljárás hosszát szükségtelenül nyújtja meg és odafigyeléssel elkerülhető lenne.
Q9: Mi a vizsgált hatóanyagot tartalmazó preparátum hivatalos magyar megnevezése?
A9: Vizsgálati gyógyszer a helyes megnevezés.
Q10: Mire kell a lényeges módosítási kérelmek esetében speciálisan ügyelni?
A10: A lényeges módosítások kísérőlevelében pontosan fel kell sorolni a módosítani kívánt dokumentumokat (verziószám és kibocsátási dátum megadásával), le kell írni a módosítás lényegét és indokait és be kell nyújtani a tiszta és változás követő formátumot is. Utóbbira természetesen nincsen szükség, ha az adott dokumentum a korábbiakban még egyáltalán nem került benyújtásra.
Az ETT KFEB által tárgyalt klinikai vizsgálati kérelmek (2022-2024)
2022
| Sorszám és cím |
|---|
| 1. AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM) |
| 2. A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction |
| 3. A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weightadjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria |
| 4. A Phase 2B prospective, blinded, randomized, placebo controlled, international multicenter study to assess restoration of coronary artery blood flow and resolution of ST segment deviation after a single subcutaneous injection of RUC-4 in subjects with ST-elevation myocardial infarction presenting in the ambulance (pre-hospital setting) |
| 5. A Phase 3, Randomized, Double-Blind Study of MK-7684A in Combination with Etoposide and Platinum Followed by MK-7684A vs Atezolizumab in Combination with Etoposide and Platinum Followed by Atezolizumab for the First-Line Treatment of Participants with Extensive-Stage Small Cell Lung Cancer |
| 6. An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers |
| 7. A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation |
| 8. Randomised, double-blind, placebo-controlled and parallel dose group trial to investigate efficacy and safety of multiple doses of oral BI 690517 over 14 weeks, alone and in combination with empagliflozin, in patients with diabetic and non-diabetic chronic kidney disease |
| 9. Evaluation of the bioequivalence of two products containing aripiprazole: Aripiprazole LAI powder and solvent for prolonged-release suspension for intramuscular injection, 400mg, Greece (Test) vs. ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension, for intramuscular use, 400mg, USA (Reference). A multicentric, multi-national, open-label, randomized, multiple dose, two-period, crossover pharmacokinetic study in schizophrenic patients |
| 10. A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE) |
| 11. READY 2: A PHASE 3, OPEN LABEL, SINGLE ARM STUDY ON THE USE OF CUSA-081 FOR DYSFUNCTIONAL CENTRAL VENOUS ACCESS DEVICES (CVADs) |
| 12. A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T) |
| 13. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib 100 mg b.i.d. versus teriflunomide 14 mg q.d. in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib |
| 14. OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS |
| 15. A phase Ib/II open label dose confirmation, proof of concept study of siremadlin in combination with venetoclax plus azacitidine in unfit adult AML participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment and in participants with newly diagnosed unfit AML presenting with high-risk clinical features. |
| 16. A randomised, double-blind, placebo-controlled, parallel group, dosefinding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis |
| 17. A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE AFTER CONVERSION FROM AN ERYTHROPOIESIS-STIMULATING AGENT |
| 18. A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Tamibarotene Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed Adult Patients Selected for RARA-positive Higher-risk Myelodysplastic Syndrome |
| 19. A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAIVE TO ERYTHROPOIESIS-STIMULATING AGENTS |
| 20. AN OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF REN001 IN SUBJECTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM) |
| 21. A Randomised, Double-Blind, Placebo-controlled study of ALPN-101 in Systemic Lupus Erythematosus |
| 22. A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer |
| 23. Master protocol of two randomized, double blind, placebo-controlled, multicenter, parallel group studies to evaluate the efficacy and safety of dupilumab in adult patients with chronic pruritus of unknown origin (CPUO) |
| 24. Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI P/0145/2019 |
| 25. A PHASE IIIB, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED STUDY OF THE EFFECTIVENESS AND SAFETY OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT TREAT & EXTEND IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (DIAGRID) |
| 26. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy |
| 27. A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). |
| 28. A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD) |
| 29. A Randomized, Phase 3, Double Masked, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of ALT L9 Versus Eylea® in Patients With Neovascular Age Related Macular Degeneration (ALTERA) |
| 30. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA |
| 31. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 IN COMBINATION WITH RANIBIZUMB ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMA |
| 32. A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB COMPARED WITH ATEZOLIZUMAB AS MAINTENANCE THERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL-CELL LUNG CANCER (ES-SCLC) FOLLOWING FIRST-LINE INDUCTION THERAPY WITH CARBOPLATIN, ETOPOSIDE AND ATEZOLIZUMAB |
| 33. AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER SPONSORED AVELUMAB CLINICAL STUDIES |
| 34. AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA |
| 35. Phase 1 Pharmacokinetics and Safety Study of Oral Soticlestat in Participants with Moderate or Severe Hepatic Impairment and Normal Hepatic Function |
| 36. AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS >= 18 AND =< 80 WITH ACTIVE DERMATOMYOSITIS. |
| 37. A Phase 1b study in patients with acromegaly or functioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of Debio 4126, a 12-week prolonged-release octreotide formulation |
| 38. A Phase 1, first-in-human, three-part, randomized, double-blind, placebocontrolled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SAR443726 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis. |
| 39. postMONARCH: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib plus Fulvestrant to Placebo plus Fulvestrant in Participants with HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy |
| 40. A Three-Part, Phase 1, Randomized, Controlled, Dose-Escalation Study of INT-787 Following Single or Multiple Dose Administration in Healthy Subjects |
| 41. A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022) |
| 42. A randomized double blind placebo controlled multicenter study to assess the efficacy and tolerability of tolperisone as add on treatment with standardized NSAID of acute non specific low back pain. |
| 43. Phase I /II, open label, dose escalation part (phase I) followed by non-comparative expansion part (phase II), multi-centre study, evaluating safety, pharmacokinetics and efficacy of S65487, a Bcl2 inhibitor combined with azacitidine in adult patients with previously untreated acute myeloid leukemia not eligible for intensive treatment |
| 44. A Phase I, Randomised, Open-Label, Single-Dose, Two-Treatment, Two-Way Crossover, Two-Stage Study to Evaluate the Bioequivalence of Onivyde (Irinotecan Liposome Injection) Manufactured at Two Different Sites Administered in Combination with Anti-Cancer Agents in Adult Participants with Metastatic Pancreatic Adenocarcinoma |
| 45. A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients with PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, with an Observational Follow-up of PSMA-PET-Negative Patients. |
| 46. Comparison of the preventive painkiller effect of etoricoxib and celecoxib after M3M surgery: A randomized, double-masked clinical trial |
| 47. A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) |
| 48. A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy. |
| 49. A Randomized, Double-Blind, Placebo controlled Study Assessing the Longterm Effect of Dupilumab on Prevention of Lung Function Decline in Patients with Uncontrolled Moderate to Severe Asthma |
| 50. An Open-Label, Multicenter, Phase 2 Study of the Safety and Efficacy of KRT-232 in Subjects with Relapsed or Refractory Small Cell Lung Cancer (SCLC) |
| 51. A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) |
| 52. A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon) |
| 53. A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Non-pharmacologically Treated Acromegaly |
| 54. LuCa-MERIT-1: First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer. |
| 55. A randomized, double-blind, parallel group, placebo-controlled, multicenter Phase 3 trial to evaluate the efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with active lupus nephritis (SIRIUS-LN) |
| 56. A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid |
| 57. A randomized, multicenter, double-blind, Phase 3 study of amcenestrant (SAR439859) versus tamoxifen for the treatment of patients with hormone receptor-positive, human epidermal growth factor 2-negative or positive, stage IIB-III breast cancer who have discontinued adjuvant aromatase inhibitor therapy due to treatment-related toxicity |
| 58. A Phase III, Randomized, Doubleblind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Nonsmall Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinumbased Concurrent Chemoradiation Therapy (PACIFIC-8) |
| 59. A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold Agglutinin Disease (CAD) |
| 60. MAGNETISMM-7 A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA WHO ARE MINIMAL RESIDUAL DISEASE POSITIVE AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION |
| 61. Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies |
| 62. A phase III, randomized, double-masked, placebo controlled, parallel-group, multicenter study of the safety and efficacy of OT-101 (Atropine 0.01%) in treating the progression of myopia in pediatric subjects |
| 63. A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea® in Subjects with Neovascular (wet) Age related Macular Degeneration (ALVOEYE) |
| 64. A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13 |
| 65. IOCYTE AMI-3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Intravenous FDY-5301 in Patients with an Anterior ST-Elevation Myocardial Infarction |
| 66. A Phase I, Open-Label Study to Evaluate the Pharmacokinetics of Tezepelumab in Children >= 5 to 11 Years of Age with Mild, Moderate, or Severe Asthma (TRAILHEAD) |
| 67. A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared with Insulin Degludec in Participants with Type 2 Diabetes Currently Treated with Basal Insulin (QWINT-3) |
| 68. A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation |
| 69. A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction |
| 70. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Crohn’s Disease |
| 71. A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) (CAPItello-280) |
| 72. A randomised, openlabel, multi-centre, two-arm Phase 3 study comparing futuximab/modotuximab in combination with trifluridine/tipiracil to trifluridine/tipiracil single agent with a Safety Lead-In part in participants with KRAS/NRAS and BRAF wild type metastatic colorectal cancer previously treated with standard treatment and anti-EGFR therapy (COLSTAR) |
| 73. A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE |
| 74. A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) |
| 75. A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation |
| 76. A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease |
| 77. A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis |
| 78. A non-randomized, open-label, 2-part, parallel-cohort trial to evaluate 1) pharmacokinetics, safety, and tolerability of a single dose of BI 456906 in patients with cirrhosis and varying degrees of hepatic impairment relative to healthy subjects and 2) safety and tolerability of multiple doses of BI 456906 in patients with overweight/obesity with cirrhosis and varying degrees of hepatic impairment relative to patients with overweight/obesity without cirrhosis/hepatic impairment |
| 79. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis |
| 80. A phase III randomized, controlled, open-label, multicenter, global study of capmatinib in combination with osimertinib versus platinum – pemetrexed based doublet chemotherapy in patients with locally advanced or metastatic NSCLC harboring EGFR activating mutations who have progressed on prior EGFR-TKI therapy and whose tumors are T790M mutation negative and harbor MET amplification (GEOMETRY-E) |
| 81. A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE |
| 82. A Subject-Blinded First-In-Human Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of AST-004 As a Short Intravenous Infusion in Healthy Adult Subjects |
| 83. A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)” |
| 84. A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE” |
| 85. A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED ≥ 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS ON EMICIZUMAB PROPHYLAXIS” |
| 86. Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group” |
| 87. A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy” |
| 88. A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTEC93/GOG-3064/ENGOT-en15)” |
| 89. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib” |
| 90. A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)” |
| 91. A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib” |
| 92. A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II” |
| 93. A PHASE Ia/Ib DOSE-ESCALATION AND DOSE EXPANSION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF GDC-6036 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTICANCER THERAPIES IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS WITH A KRAS G12C MUTATION” |
| 94. A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours” |
| 95. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER |
| 96. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO+TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER |
| 97. A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. |
| 98. A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF) |
| 99. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
| 100. A multi-center, randomized, double-blind, placebo controlled, parallelgroup Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE) |
| 101. A Phase 2, Randomised, Double-Blind, Placebo and Active Comparator-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD5718 Given Orally Once Daily for Twelve Weeks in Adults with Moderate-to-Severe Uncontrolled Asthma |
| 102. A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR TREATMENT OF RET-MUTATED MEDULLARY THYROID CANCER |
| 103. An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with Ruxolitinib in Janus associated Kinase Inhibitor (JAKi) Treatment-Naive Myelofibrosis (MF) Subjects and Subjects with MF who have a Suboptimal Response to Ruxolitinib |
| 104. Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT) |
| 105. Part I. A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 106. Part II. A Parallel-group (2-Arm), Randomized, Double-blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 107. An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma |
| 108. A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis |
| 109. An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy |
| 110. A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome (NEPTUNUS-2) |
| 111. A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia |
| 112. An adaptive, randomized, double-blind, dose exploration, parallel group, placebo-controlled, multicenter phase 2 trial to evaluate the efficacy, safety and tolerability of LNP023 in combination with standard-of-care with and without oral corticosteroids in patients with active lupus nephritis Class III-IV, +/- V |
| 113. A PHASE 2/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UNESBULIN IN UNRESECTABLE OR METASTATIC, RELAPSED OR REFRACTORY LEIOMYOSARCOMA |
| 114. A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis |
| 115. A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator’s Choice of Chemotherapy in Patients who are not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast02) |
| 116. A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors with FGFR2b Overexpression (FORTITUDE 301) |
| 117. A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Nemolizumab in Subjects with Chronic Kidney Disease with Associated Severe Pruritus |
| 118. A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera |
| 119. A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| 120. A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD) |
| 121. A Parallel Group Multiple Ascending Dose, Phase 1, Double-Blind, 5-Cohort Study to Investigate the Safety and Pharmacokinetics of NTRX 07 in Male or Female Healthy Volunteers and Patients with Early Alzheimer’s Disease (AD), with an Exploratory Fed-Fasted Assessment |
| 122. A phase 3, multicenter, multinational, randomized, double-blind, doubledummy, active-comparator study to evaluate the efficacy and safety of venglustat in adult and pediatric patients with Gaucher disease Type 3 (GD3) who have reached therapeutic goals with Enzyme Replacement Therapy (ERT) |
| 123. Part I. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure |
| 124. Part II A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure |
| 125. A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose and annual revaccination doses of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above. |
| 126. MAJIC: A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib plus Venetoclax versus Venetoclax plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| 127. KontRASt-02: A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancer |
| 128. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors do not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting whose Tumors do Express PD-L1 |
| 129. A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa |
| 130. Part I. Efficacy and Safety of AXL-Inhibitor bemcentinib for the Treatment of Moderate COVID-19 |
| 131. A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Spontaneous Urticaria |
| 132. A Randomized, Parallel Design, Multiple-Site Study to Evaluate the noninferiority of generic Clotrimazole 10mg/g cream (Antibiotice SA) compared to Canesten® 10mg/g cream in Patients with Tinea Pedis |
| 133. A Phase II, double-blind, randomized, multiple dose, cross over, threetreatment, three-period, six sequence placebo controlled trial to evaluate efficacy, pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of glycopyrronium (bromide) in children from 6 to less than 12 years of age with asthma |
| 134. A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis |
| 135. A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102) |
| 136. A phase Ia/Ib, open label, dose-escalation study of the combination of BI 907828 with BI 754091 (ezabenlimab) and BI 754111 and the combination of BI 907828 with BI 754091 (ezabenlimab) followed by expansion cohorts, in patients with advanced solid tumors |
| 137. A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers |
| 138. A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera |
| 139. A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naive Subjects with Advanced or Metastatic PD-L1 High (TPS .50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08) |
| 140. A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation |
| 141. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease |
| 142. A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines |
| 143. Study of Females Exposed to Eleclazine |
| 144. A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744 |
| 145. A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure |
| 146. A Phase II/III, Extension Study of Orally Administered PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema due to C1-Inhibitor Deficiency (Type I or Type II) |
| 147. A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366). |
| 148. A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314) |
| 149. A Phase II/III, prospective, multi-center, randomized, 4-week, doubleblind, placebo-controlled study, designed to determine the safety, tolerability, EEG effects and efficacy of oral doses of 30 mg bid of evenamide (NW-3509) in patients with chronic schizophrenia who are symptomatic on their current second-generation antipsychotic (aripiprazole, clozapine, quetiapine, olanzapine, paliperidone, or risperidone) medication. |
| 150. ASCEND-NASH: A PHASE 2B, RANDOMIZED, MULTI-CENTER, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CRV431 IN ADULT SUBJECTS WITH NONALCOHOLIC STEATOHEPATITIS AND ADVANCED LIVER FIBROSIS |
| 151. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder |
| 152. A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD) |
| 153. A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction. |
| 154. An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer |
| 155. A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy |
| 156. Phase I, Single Blind, Single Escalating Doses Study to evaluate the Safety, Tolerability, Pharmacokinetics and Imaging (CT) Performance of Orally Administered ImageBAT in Healthy Subjects |
| 157. A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) |
| 158. A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn's Disease |
| 159. Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants withoverweight or obesityand type 2 diabetes |
| 160. A Single Dose, Double-Blind, Parallel Arm, Comparative Pharmacokinetic Study of DRL_AB, US licensed Reference Abatacept (Orencia®) and EU approved Reference (Orencia®), Administered by the Intravenous Route to Male Normal Healthy Volunteers |
| 161. D3-vitaminnal, L-lizinnel és süngomba-kivonattal (Hericium erinaceus) dúsított sajtféleség funkiconális hatásának vizsgálata önkéntes résztvevőkön. |
| 162. ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults |
| 163. A randomized, Phase 3, open label study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM) |
| 164. A randomised, double-blind, parallel, multicentre, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 (proposed denosumab biosimilar) versus Prolia® (EU-sourced) in postmenopausal women with osteoporosis (SIMBA Study) |
| 165. Investigation of once-weekly semaglutide s.c. dose-response in patients with type 2 diabetes and overweight – a participant- and investigatorblinded and sponsor open-label study |
| 166. CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination with Abiraterone plus Prednisone in Men with High-Risk Metastatic Hormone-Sensitive Prostate Cancer |
| 167. A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy |
| 168. A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA |
| 169. A Phase 1 study to evaluate safety and tolerability of single and multiple ascending doses of XEN-101 |
| 170. First-in-Human, Double-Blind, Randomised, Vehicle-Controlled Phase I/II Proof of Concept Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of BEN2293 in Patients with Mild to Moderate Atopic Dermatitis |
| 171. A 52 week study comparing the efficacy and safety of once weekly IcoSema and once weekly semaglutide, both treatment arms with or without oral anti diabetic drugs, in participants with type 2 diabetes inadequately controlled with a GLP 1 receptor agonist. COMBINE 2 |
| 172. A Phase 2, randomised, double-blind, placebo-controlled, dose escalation study to investigate the effects of IRL201805 in participants with moderately to severely active rheumatoid arthritis |
| 173. A Phase 1/2, open-label, multi-center study of the safety and efficacy of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies |
| 174. A Phase 2/3 Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema |
| 175. APPRAIS - A 24-week multicentre, randomized, double-blind, placebocontrolled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate |
| 176. Clinical study on the safety and efficacy of hydroxychloroquine administered daily as Hydroxychloroquine Meditop 200 mg film-coated tablets for 3 months in 24 patients with rheumatoid arthritis |
| 177. A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults with Dyslipidemia |
| 178. A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-CF113 in the treatment of endometriosis versus placebo after 3 medication cycles followed by 3 open-label medication cycles |
| 179. Part I. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 180. Part II. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 181. ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation |
| 182. A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY |
| 183. An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary Angioedema Type I or II |
| 184. Part I (Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors |
| 185. Part II (Peak) A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors |
| 186. A Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1) |
| 187. A randomized, double-blind, controlled, multi-center study to evaluate the efficacy and safety of dose de-escalation of orally administered filgotinib in subjects with ulcerative colitis in clinical remission |
| 188. A phase I, open-label, single-center, single-dose, parallel-group study to evaluate the pharmacokinetics of BV100 in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants |
| 189. A Phase 3b/4 Randomized, Double-blind, Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up) |
| 190. A double-blind, randomized, placebo-controlled multicenter study toinvestigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks in women with, or at high risk for developing hormone-receptor positive breast cancer |
| 191. Endothelial protection in convalecent COVID-19 patients. The effect of Sulodexide on serum levels of biomarkers for endothelial dysfunction. A prospective, randomized, placebo-controlled, investigator-initiated trial. |
| 192. A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years with Wheezing Lower Respiratory Illness |
| 193. A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Diamyd® to Preserve Endogenous Beta Cell Function in Adolescents and Adults with Recently Diagnosed Type 1 Diabetes, Carrying the Genetic HLA DR3-DQ2 Haplotype |
| 194. A trial of prednisolone in combination with SPI-62 or placebo in subjects with polymyalgia rheumatica (PMR) |
| 195. A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase |
| 196. A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA |
| 197. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 |
| 198. Effectiveness and pharmacokinetic /pharmacodynamic study of Furazidin, prolonged- release tablets, 200 mg in the treatment of patients with uncomplicated lower urinary tract infections (acute or recurrent). FUTURE |
| 199. An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder |
| 200. A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease, treated with standard of care: cholinesterase inhibitors, memantine |
| 201. A multicenter, participant and investigator-blinded, randomized, placebo-controlled Phase 2a study to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of TIN816 in the treatment of patients with sepsis-associated acute kidney injury |
| 202. An Open-label Extension Study to Evaluate Longterm Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT) |
| 203. A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, with and without Intermittent LowDose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large BCell Lymphoma (VITALIZE). |
| 204. A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with moderate or severe COVID-19 |
| 205. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myopathies |
| 206. A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2306 with Cosentyx® in Patients with Moderate to Severe Plaque Psoriasis |
| 207. A 24-Week, Multicenter, Randomized, Open-Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla-300) and Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial |
| 208. A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes |
| 209. Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy |
| 210. Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma |
| 211. A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination with Irinotecan versus Investigator’s Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer (SCLC) Patients (LAGOON Trial) |
| 212. A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Birch Pollen-induced Allergic Rhinoconjunctivitis with or without Asthma |
| 213. A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304) |
| 214. A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment |
| 215. KontRASt-06: An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression < 1% or a PD-L1 expression ≥ 1% and an STK11 co-mutation |
| 216. A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer |
| 217. PART I (2022-500302-18-00) A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures |
| 218. PART I (2022-500290-14-00) A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 219. PART II (2022-500290-14-00) A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 220. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Induction Study of ADS024 in Participants with Mild to Moderate Ulcerative Colitis (UC) followed by an Optional Open-Label Extension (OLE)" |
| 221. A phase 2, open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate the efficacy and safety in patients with selected advanced/refractory solid tumors |
| 222. A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer |
| 223. A pivotal Phase II randomised, multi-centre, open label study to evaluate the efficacy and safety of MB CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B cell lymphoma (R R DLBCL), who are not eligible for high dose chemotherapy and autologous stem cell transplantation |
| 224. A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma |
| 225. A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis |
| 226. A Phase 1, open-label, study to investigate the pharmacokinetics and safety of remibrutinib (LOU064) in participants with hepatic impairment compared to matched healthy participants with normal hepatic function |
| 227. Efficacy and safety of SAR441344 in the treatment of Systemic Lupus Erythematosus: A randomized, double blind, placebo-controlled, Phase 2, proof of concept study |
| 228. A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart Failure |
| 229. A Phase 1 Single Center Open-label, Non-randomized, Fixed Sequence Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of BV100 When Administered Alone and With Itraconazole |
| 230. PART I A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis |
| 231. PART II A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults with Dermatomyositis |
| 232. A PHASE 2B RANDOMIZED, DOUBLE-BLIND, ACTIVE-AND PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE COMBINATION THERAPY WITH GUSELKUMAB AND GOLIMUMAB IN PARTICIPANTS WITH MODERATELY TO SEVERELYACTIVE CROHN’S DISEASE – DUET-CD |
| 233. A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 in Adult Participants With Schizophrenia |
| 234. A multi-center, randomized, double-blind, parallel-group, 20-week dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with resistant hypertension |
| 235. An open-label, non-randomized Phase I investigation of human ADME (absorption, distribution, metabolism and excretion) and absolute oral bioavailability of BI 907828 in patients with advanced solid tumours |
| 236. A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR |
| 237. Prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of NT 201 in the treatment of lower limb spasticity caused by stroke or traumatic brain injury in adult subjects, followed by an open label extension with or without combined upper limb treatment |
| 238. A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA |
| 239. PART I A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma |
| 240. PART II A Phase 1-2, Open-Label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of Tolinapant in Combination with Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Subjects with Relapsed/Refractory Peripheral T-cell Lymphoma |
| 241. AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED |
| 242. A PHASE 2B RANDOMIZED, DOUBLE-BLIND, ACTIVE-AND PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE COMBINATION THERAPY WITH GUSELKUMAB AND GOLIMUMAB IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS DUET-UC |
| 243. A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP) |
| 244. A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate to-severe asthma |
| 245. PART I A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults with Moderate or Severe Diabetic Foot Infections |
| 246. PART II A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults with Moderate or Severe Diabetic Foot Infections |
| 247. A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial investigating the efficacy, safety, and tolerability of two different doses of buntanetap or placebo in patients with early Parkinson’s disease |
| 248. PART I A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) |
| 249. PART II A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing CC-92480 (BMS-986348), Carfilzomib, and Dexamethasone (480Kd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) |
| 250. Part I. A double-blind, randomized, placebo-controlled, interventional, multicenter, phase III clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB) |
| 251. Part II. A double-blind, randomized, placebo-controlled, interventional, multicenter, phase III clinical trial to investigate the safety and efficacy of ABCB5-positive mesenchymal stromal cells (ABCB5+ MSCs) on epidermolysis bullosa (EB) |
| 252. Part I. A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2 |
| 253. Part II. A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2 |
| 254. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3540378 in Adults with Worsening Chronic Heart Failure with Preserved Ejection Fraction (HFpEF) |
| 255. A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease |
| 256. A multicenter, randomized, double-blind, placebocontrolled, parallel-arm study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of negative symptoms of schizophrenia |
| 257. A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, "Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy |
| 258. A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up) |
| 259. Phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12-17 years of age) with moderate-to-severe plaque psoriasis Short Title: Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis |
| 260. A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma |
| 261. An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) |
| 262. Part I. A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION |
| 263. Part II. A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION |
| 264. A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of Two Doses of INV-202 in Patients with Diabetic Kidney Disease |
| 265. An Open-Label, Safety, Tolerability, and Proof-of-Concept Study of Oral BCX9930 Therapy in Subjects with Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, or Primary Membranous Nephropathy |
| 266. Part I Phase 3, single-arm, multicenter, multinational, open-label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged ≥ 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX |
| 267. Part II Phase 3, single-arm, multicenter, multinational, open-label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged ≥ 12 years with severe hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX |
| 268. A multicenter study of secukinumab, with a randomized double-blind, placebo-controlled withdrawal-retreatment period, to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission |
| 269. A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer |
| 270. An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of avacincaptad pegol (Complement C5 Inhibitor) in Patients with Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2) |
| 271. A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono) |
| 272. A 14-Week Phase 2b, RandomizEd, Double-BLind, Dose-Ranging Study to Determine the PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD) |
| 273. A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately to Severely Active Crohn’s Disease with an Inadequate Response to Conventional Therapy |
| 274. Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults with Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B) |
| 275. A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 in Adult Participants with Active Systemic Lupus Erythematosus |
| 276. A Randomized, Double-Blind, International Multicenter, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab Injection (Prolia®) in Postmenopausal Women with Osteoporosis at High Risk of Fracture |
| 277. Part I. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus |
| 278. Part II. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus |
| 279. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression |
| 280. A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects with Community-Acquired Bacterial Pneumonia (CABP) |
| 281. Part I. Efficacy and safety of Baricitinib for the treatment of severe COVID-19 A double bind, multicentre, randomized, placebo-controlled, phase 3 trial to investigate the safety and efficacy of baricitinib + standard of care (SoC) compared with placebo + SoC on the occurrence of death in male and female participants aged > 18 years with severe COVID-19 |
| 282. Part II. Efficacy and safety of Baricitinib for the treatment of severe COVID-19 A double bind, multicentre, randomized, placebo-controlled, phase 3 trial to investigate the safety and efficacy of baricitinib + standard of care (SoC) compared with placebo + SoC on the occurrence of death in male and female participants aged > 18 years with severe COVID-19 |
| 283. A Phase 2, Multicenter, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects with Moderate to Severe, Active Rheumatoid Arthritis with Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti rheumatic Drug or a Janus Kinase Inhibitor |
| 284. Part I. A Parallel-group (2-Arm), Randomized, Double blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 285. Part II. A Parallel-group (2-Arm), Randomized, Double blind, 12-week Trial to Evaluate the Efficacy and Safety of MC2-25 Cream and MC2-25 Vehicle in Subjects with Chronic Kidney Disease-associated Pruritus (CKD-aP) |
| 286. Part I. A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations (BELLWAVE-008) |
| 287. Part II. A Phase 3, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib Versus Chemoimmunotherapy for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Without TP53 Aberrations (BELLWAVE-008) |
| 288. A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF) |
| 289. A Phase II Multicenter, open label, non-randomized study of neoadjuvant and Adjuvant Treatment with IPH5201 and durvalumab in patients with resectable, early-Stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE) |
| 290. A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with R-CHOP compared to R-CHOP in Subjects with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) |
| 291. A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) |
| 292. A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST) |
| 293. Adjustable brodalumab dosage regimen compared with standard brodalumab treatment for 52 weeks in subjects with moderate-to-severe plaque psoriasis and ł120 kg body weight; ADJUST |
| 294. A Randomized, Double-blind, Multicenter, Parallel-Group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-Severe Anhedonia and Inadequate Response to Current Antidepressant Therapy |
| 295. A Randomized, Double-blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of Single Ascending Doses of REGN5381, an NPR1 Agonist, in Heart Failure Patients with Elevated Pulmonary Capillary Wedge Pressure and Reduced Left Ventricular Ejection Fraction |
| 296. NT-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease; a prospective randomized trial |
| 297. Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in |
| 298. A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants with Active Psoriatic Arthritis – AFFINITY |
| 299. A phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1) |
| 300. A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke. |
| 301. A phase 2, randomized, double-blind, placebo controlled, dose ranging, dose finding, parallel group study to assess efficacy and safety of pf-07081532, and open label oral semaglutide, in adults with type 2 diabetes mellitus (t2dm) inadequately controlled on metformin, and separately pf-07081532 compared to matching placebo in adults with obesity but without t2dm |
| 302. A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA |
| 303. Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study of Sonelokimab in Patients with Active Psoriatic Arthritis |
| 304. A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1) |
| 305. A Randomized, Double-Blind, International Multicenter, Phase HI Study to Evaluate the Anti—Tumor Efficacy and Safety of I-ILXIO (Recombinant Humanized Anti—PD-I Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited—Stage Small Cell Lung Cancer (LS-SCLC) |
| 306. A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had insufficient response or relapsed after first line steroid treatment (VAYHIT2) |
| 307. A randomized, double-blind, placebo-controlled, parallelgroup, 12-week Proof-of-Concept (PoC) study to assess the efficacy, safety, and tolerability of rilzabrutinib in participants with moderate-to-severe asthma who are not well controlled on inhaled corticosteroid (ICS) plus longacting a 2 adrenergic agonist (LABA) therapy |
| 308. Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity |
| 309. Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity and type 2 diabetes |
| 310. A randomized, open-label, ravulizumab-controlled, noninferiority study to evaluate the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria who are complement inhibitor treatment-naive or have not recently received complement inhibitor therapy |
| 311. A Randomized, Open-Label Eculizumab and Ravulizumab Controlled, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who are Currently Treated with Eculizumab or Ravulizumab |
| 312. A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy |
| 313. A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA) |
| 314. LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy |
| 315. Part I. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Once-Daily LY3473329 in Adults with Elevated Lipoprotein(a) at High Risk for Cardiovascular Events |
| 316. Part II. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Once-Daily LY3473329 in Adults with Elevated Lipoprotein(a) at High Risk for Cardiovascular Events |
| 317. A Phase I, Double-blind, Randomized, Three-arm, Parallel Group, Study to Compare the Pharmacokinetics and Safety of a Single Subcutaneous Dose of PBP1502, EU-Humira®,and US-Humira®in Healthy Male and Female Subjects |
| 318. A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician’s Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants with Relapsed or Refractory Mantle Cell Lymphoma |
| 319. A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients with Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2) |
| 320. An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the adolescent ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE) |
| 321. A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus |
| 322. A randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery |
| 323. Part I. A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity |
| 324. Part II. A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity |
| 325. Part II. An Open-label Extension Study to Evaluate Longterm Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia (BOLD-EXT) |
| 326. An Open-label, Long-term, Safety and Efficacy Study of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) |
| 327. A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, 4-ARM STUDY TO INVESTIGATE SYMPTOMS, FUNCTION, HEALTH-RELATED QUALITY OF LIFE AND SAFETY WITH REPEATED SUBCUTANEOUS ADMINISTRATION OF PONSEGROMAB VERSUS PLACEBO IN ADULT PARTICIPANTS WITH HEART FAILURE |
| 328. Part I. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 329. Part II. ALB-TRIAL: Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites |
| 330. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY) |
| 331. An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies |
| 332. A phase I, open-label, single-center, adaptive, multiple-dose trial to evaluate the safety, tolerability and pharmacokinetics of norucholic acid in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants |
| 333. A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects with Moderate-to-Severe Pruritus and not on Dialysis with an up to 52-Week Long-term Extension |
| 334. A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis |
| 335. A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies |
| 336. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD |
| 337. Part I. A Phase 2/3, Multicenter, Randomized, Double-blind, Placebocontrolled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder |
| 338. Part II. A Phase 2/3, Multicenter, Randomized, Double-blind, Placebocontrolled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder |
| 339. A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants with Hematologic Malignancies |
| 340. A Multicentre, Open label, Randomised, Controlled, Basket, Pragmatic, Phase II, Clinical and Translational Study to Determine the Efficacy and Safety of Plitidepsin versus Control in Immunocompromised Adult Patients with Symptomatic COVID-19 requiring Hospital Care (NEREIDA) |
| 341. Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in patients suffering from Acute Respiratory Distress Syndrome (ARDS): a double-blind, randomized, placebo-controlled, multicenter Phase 2a/b clinical trial |
| 342. Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases |
| 343. A phase 1b double-blind, randomized, placebo-controlled, multicenter, dose titration study to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks treatment with BAY 2413555 in participants with heart failure and implanted cardiac defibrillator or cardiac resynchronization devices |
| 344. A phase I/II, open-label, multi-cohort study to evaluate the efficacy and safety of cevostamab in prior b cell maturation antigen-exposed patients with relapsed/refractory multiple myeloma |
| 345. A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy |
| 346. An Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst sponsored Study |
| 347. An open label, Phase IV study to assess immunological changes in patients with glioblastoma multiforme treated with bevacizumab infusion |
| 348. A Phase 1 Open-label Study to Evaluate the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of BCX10013 in Subjects with Varying Degrees of Renal Impairment |
| 349. Part I. A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2) |
| 350. Part II. A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-2) |
| 351. Part I. A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain |
| 352. Part I. A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis |
| 353. Part II. A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis |
| 354. Part I. A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction (VALOR) |
| 355. Part II. A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction (VALOR) |
| 356. Part I. A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP) |
| 357. A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-Label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1) |
| 358. ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES |
| 359. Part I. A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence |
| 360. Part II. A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence |
Módosítási kérelmek száma 2022-ben: 2221
2023
| Sorszám és cím |
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| 1. A Phase 3, Multi-center, Randomized, Quadruplemasked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED) |
| 2. A multicenter, open-label, randomized, active-controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available therapy in adult patients with ventilator-associated bacterial pneumonia suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii |
| 3. A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA) |
| 4. A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy |
| 5. A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab (MEDI3506) in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA) |
| 6. An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria |
| 7. A Phase 2, Randomized, Placebo-Controlled, Parallel-Group, Double-Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren’s Syndrome |
| 8. A randomized, double-blind, three-part, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending (SAD17663) and multiple ascending (MAD17664) doses of SAR444419 in healthy adult participants and of a single dose (PDY17062) of SAR444419 in adult participants with moderate-to-severe rheumatoid arthritis |
| 9. A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients with Phlebotomy Dependent Polycythemia Vera (PD-PV) |
| 10. A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG) |
| 11. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis |
| 12. A phase 3, randomized, placebo-controlled, double-blind, multicenter trial of selinexor in maintenance therapy after systemic therapy for patients with p53 wild-type, advanced or recurrent endometrial carcinoma |
| 13. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - The RECLAIIM Study |
| 14. PART I A Phase 3, Open-label, 52 week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 years With Moderate to severe Atopic Dermatitis (AD) (ROCKET-Orbit) |
| 15. PART II "A Phase 3, Open-label, 52 week Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab (AMG 451) in Adolescent Subjects Aged ≥ 12 to < 18 years With Moderate to severe Atopic Dermatitis (AD) (ROCKET-Orbit) |
| 16. Phase 1, Open-label, Single-Dose Study to Determine the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of TL-895 in Adult Subjects |
| 17. Evaluation of the bioequivalence of two products containing aripiprazole: Aripiprazole LAI powder and solvent for prolonged-release suspension for intramuscular injection, 400mg, Greece (Test) vs. ABILIFY MAINTENA® (aripiprazole) for extended-release injectable suspension, for intramuscular use, 400mg, USA (Reference). A multicentric, multi-national, open-label, randomized, multiple dose, two-period, crossover pharmacokinetic study in schizophrenic patients |
| 18. A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD |
| 19. Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies |
| 20. A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma |
| 21. An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid |
| 22. A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7) |
| 23. A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis |
| 24. Phase 3 Multicenter, Randomized, Double-Blind, Study to "Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2) |
| 25. A multicenter rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy who have completed study CLNP023X2203 or CLNP023A2301 |
| 26. Part I. "A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia |
| 27. Part II. A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia |
| 28. Part I. A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallelgroup, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations (PROSPERO) |
| 29. Part II. A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallelgroup, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants with Chronic Obstructive Pulmonary Disease (COPD) with a History of Exacerbations (PROSPERO) |
| 30. Part I. A Phase 3, 24-week, Randomized, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET Ignite) |
| 31. Part II. A Phase 3, 24-week, Randomized, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET Ignite) |
| 32. Part I. A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis |
| 33. Part II. A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis |
| 34. A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of carisbamate (YKP509) as adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome in children and adults, with optional open-label extension |
| 35. Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B Well 1) |
| 36. A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients with Idiopathic Pulmonary Fibrosis |
| 37. A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated quavonlimab (MK-1308)/pembrolizumab) Versus Other Treatments in Participants with Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008) |
| 38. An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subjects with HER2+ Metastatic Colorectal Cancer |
| 39. A Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist |
| 40. An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED) |
| 41. A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea® in Subjects with Neovascular (wet) Age related Macular Degeneration (ALVOEYE) |
| 42. A Phase 2 Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Narsoplimab in Paediatric Patients (28 Days to 18 Y.O.) with High Risk Haematopoietic Stem Cell Transplant Thrombotic Microangiopathy |
| 43. PART I A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07) |
| 44. PART II A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07) |
| 45. Phase I/II multicenter study to assess efficacy and safety of ribociclib (LEE011) in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory neuroblastoma and other solid tumors |
| 46. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zilovertamab (an ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Subjects with Relapsed or Refractory Mantle Cell Lymphoma |
| 47. A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis |
| 48. A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis |
| 49. Open-label, multicenter, multinational, interventional Clinical Trial to assess Efficacy and Safety of the extemporaneous combination of Nebivolol and Ramipril in hypertensive patients - ARTEMISIA study |
| 50. A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose ranging Study to Assess the Efficacy and Safety of CDX-0159 in Patients with Chronic Inducible Urticaria |
| 51. A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease |
| 52. An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| 53. Phase IV study comparing the efficacy and safety of an alcohol-free formulation of 0.15% benzydamine hydrochloride spray and benzydamine hydrochloride 3mg lozenges in paediatric patients (6-12 years) with sore throat |
| 54. A 24-Week, Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy Safety, and Tolerability of TEV-48574 in Adult Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who completed the treatment phase of the Dose-Ranging Study |
| 55. A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole HCl) as Adjunctive Therapy in Patients with Dravet Syndrome (ARGUS trial) |
| 56. A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5) |
| 57. A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants with Crohn’s Disease After Surgical Resection |
| 58. A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Furmonertinib Compared to Platinum-Based Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Exon 20 Insertion Mutations |
| 59. A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B |
| 60. Part I A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer |
| 61. PART II A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer |
| 62. A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A |
| 63. Multi-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis |
| 64. A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
| 65. A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study |
| 66. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants with Moderately to Severely Active Crohn’s Disease |
| 67. An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome |
| 68. An Open-Label, 2-Arm, Multicenter, Randomized Phase 3 Study To Evaluate The Efficacy And Safety of Elranatamab (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Transplant-Ineligible Participants With Newly-Diagnosed Multiple Myeloma |
| 69. A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of TW001 in Alzheimer Patients |
| 70. An Integrated Phase I/II, Multicentre, Double-Blind, Randomised, Dysport and Placebo-Controlled, Dose-Escalation and Dose-Finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity |
| 71. An open-label, parallel-group study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cenerimod after single-dose administration in subjects with hepatic impairment and in healthy subjects |
| 72. A multicenter, open-label, Phase IIb study to evaluate the efficacy, safety and pharmacokinetics of rilzabrutinib in patients with warm autoimmune hemolytic anemia |
| 73. A Phase 1, open-label study to investigate the pharmacokinetics and safety of remibrutinib (LOU064) in participants with renal impairment compared to matched healthy participants with normal renal function |
| 74. A First-in-Human, Multicenter, Phase 1/2, Open-Label Study of XTX202 in Patients with Advanced Solid Tumors |
| 75. Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation |
| 76. A Phase I Dose Escalation Study of NMS-03305293 in Adult Patients with Selected Advanced/Metastatic Solid Tumors |
| 77. Performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas |
| 78. A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients with Active Psoriatic Arthritis |
| 79. A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49) |
| 80. Part I A Phase 1 Study to Investigate the Absolute Bioavailability and Absorption, Metabolism, and Excretion of 14C-Unesbulin in Patients With Advanced Solid Tumor |
| 81. Part II A Phase 1 Study to Investigate the Absolute Bioavailability and Absorption, Metabolism, and Excretion of 14C-Unesbulin in Patients With Advanced Solid Tumor |
| 82. PART I A Randomized, Double-Blind, Placebo-Controlled Multicenter Study To Evaluate The Efficacy And Safety Of CAL02 Administered Intravenously In Addition To Standard Of Care In Subjects With Severe Community-Acquired Bacterial Pneumonia (SCABP) |
| 83. Randomized, double-blind, placebo controlled clinical trial of (+)-?-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia |
| 84. PART I A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with IgG4-Related Disease (INDIGO) |
| 85. PART II A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients with IgG4-Related Disease (INDIGO) |
| 86. Phase 1/2, Open label & double blind randomized placebo-controlled study to assess the feasibility of BGC101 (EnEPC) in the treatment of peripheral arterial disease (PAD) with critical limb ischemia (CLI) |
| 87. PANOVA-4: Pilot, Single arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) |
| 88. PART I A Phase 3, Randomized, 24-week, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET SHUTTLE) |
| 89. PART II A Phase 3, Randomized, 24-week, Placebo controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET SHUTTLE) |
| 90. PART I A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO) |
| 91. PART II A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO) |
| 92. PART I A parallel-group treatment, proof-of-concept Phase 2, multicenter, double-blind, randomized two-arm clinical trial to investigate the efficacy and safety of subcutaneous NT 201 injections compared with placebo injections in decreasing pain intensity in male and female participants aged 18 years and older with moderate to severe chronic peripheral neuropathic pain due to postherpetic neuralgia or peripheral nerve injury. |
| 93. PART II A parallel-group treatment, proof-of-concept Phase 2, multicenter, double-blind, randomized two-arm clinical trial to investigate the efficacy and safety of subcutaneous NT 201 injections compared with placebo injections in decreasing pain intensity in male and female participants aged 18 years and older with moderate to severe chronic peripheral neuropathic pain due to postherpetic neuralgia or peripheral nerve injury |
| 94. PART I A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 95. PART II A randomized, double-blind, placebo controlled, dose-finding study to assess the efficacy and safety of SAR443122 in adult patients with moderate to severe ulcerative colitis |
| 96. A Randomized, Double masked, Parallel group, Dose-finding study to evaluate SYL1801 in patients with neovascular AMD |
| 97. Part I A Phase 2, Double-Blinded, Randomized, Placebo- Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS.5290 in Participants With Moderately to Severely Active Ulcerative Colitis |
| 98. Part II A Phase 2, Double-Blinded, Randomized, Placebo- Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS.5290 in Participants With Moderately to Severely Active Ulcerative Colitis |
| 99. Part I A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) |
| 100. Part II A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2) |
| 101. Part I A Phase 3, Open Label, Randomized, Two Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard of Care Therapies in Patients with HR Positive, HER2 Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) |
| 102. A Phase 3, Open Label, Randomized, Two Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard of Care Therapies in Patients with HR Positive, HER2 Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) |
| 103. Part I A Phase 2b / 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis |
| 104. A Phase 2b / 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis |
| 105. A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B |
| 106. A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D |
| 107. Changes in airway cross sectional areas during residual neuromuscular blockade, and after reversal |
| 108. The effect of additional pre-extubational loading dose of caffeine-citrate |
| 109. A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers |
| 110. A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer |
| 111. A MULTICENTER, RANDOMIZED, OPEN-LABEL, ADAPTIVE PHASE I STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ASCENDING INTRAVENOUS DOSES OF GLOFITAMAB, ADMINISTERED AFTER OCRELIZUMAB PRETREATMENT, IN PATIENTS WITH MULTIPLE SCLEROSIS |
| 112. Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment |
| 113. A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients with Spinal Muscular Atrophy Previously Treated with Risdiplam |
| 114. PART I A Phase 3, Randomized, Open-label, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer whose disease progressed after prior endocrine based treatment for advanced disease (VERITAC-2) |
| 115. PART II A Phase 3, Randomized, Open-label, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer whose disease progressed after prior endocrine based treatment for advanced disease (VERITAC-2) |
| 116. PART I HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation |
| 117. PART II HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation |
| 118. Individualized everolimus therapy in metastatic breast cancer |
| 119. Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction ( ˂ 45%) After Myocardial Infarction (HF-REVERT) |
| 120. Implementation study of lipid management of high-risk cardiovascular patients- Semmelweis Lipid Center for high-risk patients |
| 121. Value-based health economic comparative study of subcutaneous and intravenous trastuzumab-pertuzumab for HER-2 positive metastatic breast cancer based on patient reported outcomes |
| 122. PART I A Phase 3 randomized, placebo-controlled, double-blind, parallelgroup program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis |
| 123. PART II A Phase 3 randomized, placebo-controlled, double-blind, parallelgroup program to evaluate efficacy and safety of filgotinib in adult subjects with active axial spondyloarthritis |
| 124. PART I A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia |
| 125. PART I A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a) |
| 126. PART II A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a) |
| 127. PART II A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia |
| 128. PART I A Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® plus Standard Medical Treatment Compared to Placebo plus Standard Medical Treatment to Prevent Infections in Patients with Hypogammaglobulinemia and Recurrent or Severe Infections Associated with B-cell Chronic Lymphocytic Leukemia |
| 129. PART I An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia (SHTG) |
| 130. PART II An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia (SHTG) |
| 131. PART I A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy |
| 132. PART II A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy |
| 133. PART I A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures (X-TOLE3) |
| 134. PART II A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures (X-TOLE3) |
| 135. PART I Double-blind, randomized, active-controlled, two-way cross-over study, with 12-week treatment duration per period, to evaluate the efficacy and safety of QMF149 (indacaterol acetate / mometasone furoate) compared to budesonide in children from 6 to less than 12 years of age with asthma |
| 136. PART II Double-blind, randomized, active-controlled, two-way cross-over study, with 12-week treatment duration per period, to evaluate the efficacy and safety of QMF149 (indacaterol acetate / mometasone furoate) compared to budesonide in children from 6 to less than 12 years of age with asthma |
| 137. A comparative bioavailability study of a single dose of ziltivekimab formulation B in a manual syringe, formulation D in a manual syringe and formulation C in a pen-injector |
| 138. PART II A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP |
| 139. PART I A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults with Tourette’s Disorder |
| 140. PART II A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults with Tourette’s Disorder |
| 141. PART I A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaLuate the effIcacy and safety of abeLacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC) |
| 142. PART II A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaLuate the effIcacy and safety of abeLacimab in high-risk patients with Atrial fibrillation who have been deemed unsuitable for oral antiCoagulation (LILAC) |
| 143. PART I An 18-month low-interventional prospective, multicentre study to assess joint outcomes in patients with haemophilia A or B on prophylaxis with efmoroctocog alfa or eftrenonacog alfa JOIN-us |
| 144. PART II An 18-month low-interventional prospective, multicentre study to assess joint outcomes in patients with haemophilia A or B on prophylaxis with efmoroctocog alfa or eftrenonacog alfa JOIN-us |
| 145. PART I A randomized, parallel-group, double-blind, placebocontrolled, multicenter Phase III trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR) |
| 146. PART II A randomized, parallel-group, double-blind, placebocontrolled, multicenter Phase III trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with polymyalgia rheumatica (PMR) |
| 147. PART I A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE) |
| 148. PART II A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE) |
| 149. PART I A Phase l/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity ofVBl0.16 in Combination with Pembrolizumab in Patients with Umesectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma |
| 150. PART II A Phase l/2a, Open-label, Dose-finding Trial to Evaluate Safety, Immunogenicity, and Anti-tumor Activity ofVBl0.16 in Combination with Pembrolizumab in Patients with Umesectable Recurrent or Metastatic HPV16-positive Head and Neck Squamous Cell Carcinoma |
| 151. PART I A PHASE 1/2, OPEN-LABEL, MULTI-CENTER STUDY OF ZN-c3 ADMINISTERED IN COMBINATION WITH ENCORAFENIB AND CETUXIMAB IN ADULTS WITH METASTATIC COLORECTAL CANCER |
| 152. PART I A PHASE 1/2, OPEN-LABEL, MULTI-CENTER STUDY OF ZN-c3 ADMINISTERED IN COMBINATION WITH ENCORAFENIB AND CETUXIMAB IN ADULTS WITH METASTATIC COLORECTAL CANCER |
| 153. PART I A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures (X-ACKT) |
| 154. PART I A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) |
| 155. PART II A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) |
| 156. PART I A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma |
| 157. PART II A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma |
| 158. Phase 2b, multinational, randomized, double-blind study to investigate the efficacy and safety of redasemtide (S-005151) compared with placebo in adult participants with acute ischemic stroke who are not eligible for tissue plasminogen activator or thrombectomy Part I |
| 159. Phase 2b, multinational, randomized, double-blind study to investigate the efficacy and safety of redasemtide (S-005151) compared with placebo in adult participants with acute ischemic stroke who are not eligible for tissue plasminogen activator or thrombectomy Part II |
| 160. A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eye drops 2% on visual field preservation in patients with open angle glaucoma Part I |
| 161. A phase III multicenter, double-blind, randomized, placebo-controlled, parallel-group trial of the efficacy of citicoline eye drops 2% on visual field preservation in patients with open angle glaucoma Part II |
| 162. A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome - LIBREXIA-ACS Part I |
| 163. A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome - LIBREXIA-ACS Part II |
| 164. A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation Part I |
| 165. A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation Part II |
| 166. A Phase 3 multiCenter, rAndomized, pLacebo-controlled, double-blind studY to evaluate the efficacy and safety of eneboparatide (AZP-3601), a Parathyroid hormone receptor agoniSt, in patients with chronic hypOparathyroidism (CALYPSO) Part I |
| 167. A Phase 3 multiCenter, rAndomized, pLacebo-controlled, double-blind studY to evaluate the efficacy and safety of eneboparatide (AZP-3601), a Parathyroid hormone receptor agoniSt, in patients with chronic hypOparathyroidism (CALYPSO) Part II |
| 168. A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy Part I |
| 169. A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy Part II |
| 170. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study To Evaluate The Efficacy And Safety Of CAL02 Administered Intravenously In Addition To Standard Of Care In Subjects With Severe Community-Acquired Bacterial Pneumonia (SCABP) Part II |
| 171. Interfant-21: International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia Part I |
| 172. Interfant-21: International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia Part II |
| 173. A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age Part I |
| 174. A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age Part II |
| 175. A TWO-COHORT, PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF VIXARELIMAB COMPARED WITH PLACEBO IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS AND IN PATIENTS WITH SYSTEMIC SCLEROSIS.ASSOCIATED INTERSTITIAL LUNG DISEASE Part I |
| 176. A TWO-COHORT, PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF VIXARELIMAB COMPARED WITH PLACEBO IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS AND IN PATIENTS WITH SYSTEMIC SCLEROSIS.ASSOCIATED INTERSTITIAL LUNG DISEASE Part II |
| 177. A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults with Tourette’s Disorder Part I |
| 178. A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults with Tourette’s Disorder Part II |
| 179. First-in-human, open-label Phase 1/2 study to investigate safety and efficacy of SAR445514, an NK-cell engager (NKCE) targeting B-cell maturation antigen (BCMA) in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and in relapsed/refractory lightchain amyloidosis (RRLCA) PART I |
| 180. First-in-human, open-label Phase 1/2 study to investigate safety and efficacy of SAR445514, an NK-cell engager (NKCE) targeting B-cell maturation antigen (BCMA) in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and in relapsed/refractory lightchain amyloidosis (RRLCA) PART II |
| 181. A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304) PART I |
| 182. A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-304) PART II |
| 183. CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence PART I |
| 184. CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy with Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence PART II |
| 185. A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE PART I |
| 186. A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE PART II |
| 187. A Phase 3, Randomized, Double-Blind, Parallel- Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor Xia Inhibitor, for Stroke Prevention after an Acute lschemic Stroke or High-Risk Transient lschemic Attack PART I |
| 188. A Phase 3, Randomized, Double-Blind, Parallel- Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor Xia Inhibitor, for Stroke Prevention after an Acute lschemic Stroke or High-Risk Transient lschemic Attack PART II |
| 189. A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain PART II |
| 190. A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075mg PART I |
| 191. A pivotal, multicentre, randomised, open-label, parallel-group trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 9 cycles in comparison with Desogestrel tablets 0.075mg PART II |
| 192. A multicentre, single arm trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 13 cycles. PART I |
| 193. A multicentre, single arm trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 13 cycles PART II |
| 194. A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Mavodelpar in Subjects with Impaired Hepatic Function PART I |
| 195. A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Mavodelpar in Subjects with Impaired Hepatic Function PART II |
| 196. A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and its Relationship with Other Outcome Measures in Adults with Moderately to Severely Active Ulcerative Colitis Treated with Mirikizumab PART I |
| 197. A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and its Relationship with Other Outcome Measures in Adults with Moderately to Severely Active Ulcerative Colitis Treated with Mirikizumab PART II |
| 198. A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients with Moderate-to-Severe Atopic Dermatitis part I |
| 199. A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients with Moderate-to-Severe Atopic Dermatitis part II |
| 200. A Multi-Center, Randomized, Parallel -Group, Phase 2, Masked, Three -Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared with Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects with Diabetic Macular Edema (OXEYE) part I |
| 201. A Multi-Center, Randomized, Parallel -Group, Phase 2, Masked, Three -Arm Trial to Compare Safety, Tolerability, Efficacy, and Durability of Two Dose Levels of Suprachoroidal Sustained-Release OXU-001 (Dexamethasone Microspheres; DEXAspheres®) Using the Oxulumis® Illuminated Microcatheterization Device Compared with Intravitreal Dexamethasone Implant (OZURDEX®) in Subjects with Diabetic Macular Edema (OXEYE) part II |
| 202. Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion part I |
| 203. Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion part II |
| 204. A Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® plus Standard Medical Treatment Compared to Placebo plus Standard Medical Treatment to Prevent Infections in Patients with Hypogammaglobulinemia and Recurrent or Severe Infections Associated with B-cell Chronic Lymphocytic Leukemia part II |
| 205. A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, CONTROLLED, OPEN-LABEL STUDY COMPARING IBERDOMIDE MAINTENANCE TO LENALIDOMIDE MAINTENANCE THERAPY AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) IN PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM) (EXCALIBER MAINTENANCE) part I |
| 206. A PHASE 3, TWO-STAGE, RANDOMIZED, MULTICENTER, CONTROLLED, OPEN-LABEL STUDY COMPARING IBERDOMIDE MAINTENANCE TO LENALIDOMIDE MAINTENANCE THERAPY AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) IN PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM) (EXCALIBER MAINTENANCE) part I |
| 207. A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT) part I |
| 208. A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT) part II |
| 209. A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis part I |
| 210. A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate the Efficacy and Safety of DC-806 in Participants with Moderate to Severe Plaque Psoriasis part II |
| 211. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Efficacy And Safety Of Rifaximin Soluble Solid Dispersion (SSD) Tablets For The Delay Of Encephalopathy Decompensation In Cirrhosis (RED-C) part I |
| 212. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Efficacy And Safety Of Rifaximin Soluble Solid Dispersion (SSD) Tablets For The Delay Of Encephalopathy Decompensation In Cirrhosis (RED-C) part II |
| 213. A Phase 2b Randomized, Double-Blind Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults with Precirrhotic Nonalcoholic Steatohepatitis part I |
| 214. A Phase 2b Randomized, Double-Blind Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults with Precirrhotic Nonalcoholic Steatohepatitis part II |
| 215. A randomized, open-label, multi-center phase III trial comparing tisagenlecleucel to standard of care in adult participants with relapsed or refractory follicular lymphoma part I |
| 216. A randomized, open-label, multi-center phase III trial comparing tisagenlecleucel to standard of care in adult participants with relapsed or refractory follicular lymphoma part II |
| 217. A Phase I, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Function part I |
| 218. A Phase I, Open-label, Pharmacokinetic Study of TVB-2640 in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Function part II |
| 219. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1 - POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER part I |
| 220. A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1 - POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER part II |
| 221. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata part I |
| 222. A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata part II |
| 223. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2-) (HER2-IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy part I |
| 224. A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2-) (HER2-IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy part II |
| 225. A Multicenter, Open-label, Extension Study to Evaluate the Longterm Safety of Atogepant in Pediatric Subjects 6 to 17 Years of Age with Episodic Migraine part I |
| 226. A Multicenter, Open-label, Extension Study to Evaluate the Longterm Safety of Atogepant in Pediatric Subjects 6 to 17 Years of Age with Episodic Migraine part II |
| 227. A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease (TRIUMPH-3) part I |
| 228. A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease (TRIUMPH-3) part II |
| 229. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG) part I |
| 230. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG) part II |
| 231. A long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma who completed treatment period of previous amlitelimab asthma clinical study part I |
| 232. A long-term extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma who completed treatment period of previous amlitelimab asthma clinical study part II |
| 233. A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. (Part A) followed by open label long-term safety assessment (Part B) in patients with bronchiectasis (ClairleafTM) part I |
| 234. A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. (Part A) followed by open label long-term safety assessment (Part B) in patients with bronchiectasis (ClairleafTM) part II |
| 235. A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children under 6 Years of Age with Hyperkalaemia (EMERALD 2) part I |
| 236. A 2-Part, Open-Label, Phase 2, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer in Children under 6 Years of Age with Hyperkalaemia (EMERALD 2) part II |
| 237. A double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intravenous ganaxolone added to standard of care in refractory status epilepticus part I |
| 238. A double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety, and tolerability of intravenous ganaxolone added to standard of care in refractory status epilepticus part II |
| 239. A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy part I |
| 240. A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy part II |
| 241. A multicenter, randomized, prospective doubleblind, cross-over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs) part I |
| 242. A multicenter, randomized, prospective doubleblind, cross-over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs) part II |
| 243. An Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics in Response to a Single Subcutaneous Dose of Fazirsiran (TAK-999) in Subjects With or Without Hepatic Impairment part I |
| 244. An Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics in Response to a Single Subcutaneous Dose of Fazirsiran (TAK-999) in Subjects With or Without Hepatic Impairment part II |
Módosítási kérelmek száma 2023-ban: 2009
2024
| Sorszám és cím |
|---|
| 1. Part I "A Phase 3, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn´s Disease" |
| 2. Part II "A Phase 3, Randomized, Placebo-Controlled, Double- Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn´s Disease" |
| 3. Part I "A Phase 3 Randomized, Placebo- Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Severe Alopecia Areata" |
| 4. Part II "A Phase 3 Randomized, Placebo- Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Severe Alopecia Areata" |
| 5. Part II "Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRá-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary_x000D_ peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA)" |
| 6. Part I "A Phase 3 Randomized, Open-label Study of MK,5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy" |
| 7. Part II "A Phase 3 Randomized, Open-label Study of MK,5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy" |
| 8. Part I "An Interventional, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Study to Evaluate the Relative Bioavailability of 750 mg Arvisol® CBD tablets and 750 mg Epidiolex® CBD oral solution in Healthy Adult Participants under fed conditions," |
| 9. Part II "An Interventional, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Study to Evaluate the Relative Bioavailability of 750 mg Arvisol® CBD tablets and 750 mg Epidiolex® CBD oral solution in Healthy Adult Participants under fed conditions," |
| 10. Part I "A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)" |
| 11. Part II "A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician’s Choice New Hormonal Agents in Patients with HRRm and non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)" |
| 12. Part I "A Phase Ib multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, immunogenicity, and exploratory efficacy of Ent001 in adult patients with moderately to severely active ulcerative colitis," |
| 13. Part II "A Phase Ib multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, immunogenicity, and exploratory efficacy of Ent001 in adult patients with moderately to severely active ulcerative colitis," |
| 14. Part I "A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)" |
| 15. Part II "A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)" |
| 16. Part I "A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Untreated Triple-Negative or Hormone Receptor-low-HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)" |
| 17. Part II "A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Untreated Triple-Negative or Hormone Receptor-low-HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)" |
| 18. Part I "A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis" |
| 19. Part II "A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Deucravacitinib Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis" |
| 20. Part I "A Randomised, Placebo-controlled, Double-blind, Multi-centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared With BGF Delivered by MDI HFA in Participants With Chronic Obstructive Pulmonary Disease" |
| 21. Part II "A Randomised, Placebo-controlled, Double-blind, Multi-centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared With BGF Delivered by MDI HFA in Participants With Chronic Obstructive Pulmonary Disease" |
| 22. Part I "A PHASE 1-3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAIVE PATIENTS WITH MYELOFIBROSIS" |
| 23. Part II "A PHASE 1-3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAIVE PATIENTS WITH MYELOFIBROSIS" |
| 24. Part I "A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543-IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea" |
| 25. Part II "A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543-IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea" |
| 26. Part I "A phase 3 randomized, open-label study of OP-1250 monotherapy vs standard of care for the treatment of ER+, HER2– advanced or metastatic breast cancer following endocrine and CDK 4-6 inhibitor therapy (OPERA-01)" |
| 27. Part II "A phase 3 randomized, open-label study of OP-1250 monotherapy vs standard of care for the treatment of ER+, HER2– advanced or metastatic breast cancer following endocrine and CDK 4-6 inhibitor therapy (OPERA-01)" |
| 28. Part I "Randomised, placebo-controlled Phase II proof of concept study of efficacy and safety of a novel rifamycin SV in situ gelling rectal solution administered by enema to patients with mild to moderate left-sided ulcerative colitis" |
| 29. Part II "Randomised, placebo-controlled Phase II proof of concept study of efficacy and safety of a novel rifamycin SV in situ gelling rectal solution administered by enema to patients with mild to moderate left-sided ulcerative colitis" |
| 30. Part I Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE) |
| 31. Part II Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE) |
| 32. Part I "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy" |
| 33. Part II "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy" |
| 34. Part II "A Randomized, Double-Blind, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Fluticasone Propionate-Albuterol Sulfate Fixed-Dose Combination on Severe Asthma Exacerbations in Patients with Asthma" |
| 35. Part I "A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative_x000D_ Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Nextgeneration Hormonal Agent (NHA)" |
| 36. Part II "A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative_x000D_ Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Nextgeneration Hormonal Agent (NHA)" |
| 37. Part I "A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52- WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP-DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO" |
| 38. Part II "A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52- WEEK PLACEBO-CONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP-DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO" |
| 39. Part I "A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1- antihistamines" |
| 40. Part II "A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1- antihistamines" |
| 41. Part I "A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy, and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo" |
| 42. Part II "A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy, and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo" |
| 43. Part I "A randomized, double-masked, placebo-controlled, safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)" |
| 44. Part II "A randomized, double-masked, placebo-controlled, safety, tolerability and efficacy study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with chronic thyroid eye disease (TED)" |
| 45. Part I "RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)" |
| 46. Part I "Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s,c, in doses 2,4 mg-2,4 mg and 1,0 mg-1,0 mg once weekly versus placebo in participants with type 2 diabetes inadequately controlled on diet and exercise," |
| 47. Part II "Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s,c, in doses 2,4 mg-2,4 mg and 1,0 mg-1,0 mg once weekly versus placebo in participants with type 2 diabetes inadequately controlled on diet and exercise," |
| 48. Part I "Randomized, open-label, multicenter phase 3 study to assess the efficacy and safety of GIVinostat versus hydroxyurea IN JAK2V617F-positive high-risk Polycythemia Vera patients: the GIV-IN PV TRIAL" |
| 49. Part II "Randomized, open-label, multicenter phase 3 study to assess the efficacy and safety of GIVinostat versus hydroxyurea IN JAK2V617F-positive high-risk Polycythemia Vera patients: the GIV-IN PV TRIAL" |
| 50. Part I "A Phase III, Parallel Design, Triple-Blind, Randomized, Multicenter Clinical Trial to Evaluate Safety & Efficacy of TH07 Topical Treatment in Male Patients with Androgenic Alopecia," |
| 51. Part I "A Randomized, Open-Label Phase 2-3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer" |
| 52. Part II "A Randomized, Open-Label Phase 2-3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer" |
| 53. Part I "A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension (Bax24 Study)" |
| 54. Part II "A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants with Resistant Hypertension (Bax24 Study)" |
| 55. Part I "A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 54-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients with Moderate-to-Severe Atopic Dermatitis" |
| 56. Part II "A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled 54-Week Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin in the Treatment of Adult Patients with Moderate-to-Severe Atopic Dermatitis" |
| 57. Part I "A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM" |
| 58. Part II "A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM" |
| 59. Part I "Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2,4 mg-2,4 mg) once weekly versus semaglutide 2,4 mg, cagrilintide 2,4 mg and placebo in people with chronic kidney disease and type 2 diabetes living with overweight or obesity," |
| 60. Part II "Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema 2,4 mg-2,4 mg) once weekly versus semaglutide 2,4 mg, cagrilintide 2,4 mg and placebo in people with chronic kidney disease and type 2 diabetes living with overweight or obesity," |
| 61. Part I "A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of burfiralimab (hzVSF-v13) added to disease modifying antirheumatic drugs in participants with moderate to severe rheumatoid arthritis" |
| 62. Part II "A Phase 2a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of burfiralimab (hzVSF-v13) added to disease modifying antirheumatic drugs in participants with moderate to severe rheumatoid arthritis" |
| 63. Part I "A Phase III, Randomized, Open label, Multi-center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)," |
| 64. Part II "A Phase III, Randomized, Open label, Multi-center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)," |
| 65. Part I "LIGHTBEAM-U01 Substudy 01A: A Phase 1-2 Substudy to Evaluate the_x000D_ Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors" |
| 66. Part II "LIGHTBEAM-U01 Substudy 01A: A Phase 1-2 Substudy to Evaluate the_x000D_ Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors" |
| 67. Part I "LIGHTBEAM-U01 Substudy 01B: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors" |
| 68. Part II "LIGHTBEAM-U01 Substudy 01B: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors" |
| 69. Part I "A PHASE 2-3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF ZANZALINTINIB (XL092) IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB IN THE FIRST-LINE TREATMENT OF SUBJECTS WITH PD-L1 POSITIVE RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA" |
| 70. Part II "A PHASE 2-3, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF ZANZALINTINIB (XL092) IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB IN THE FIRST-LINE TREATMENT OF SUBJECTS WITH PD-L1 POSITIVE RECURRENT OR METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA" |
| 71. Part I "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R-M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)" |
| 72. Part II "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Ficlatuzumab in Combination with Cetuximab in Participants with Recurrent or Metastatic (R-M) HPV-Negative Head and Neck Squamous Cell Carcinoma (FIERCE-HN)" |
| 73. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-tosevere Systemic Disease Activity" |
| 74. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-tosevere Systemic Disease Activity" |
| 75. Part I "A phase III, randomised, double-blind, multicentre study comparing the efficacy, safety, and immunogenicity of proposed tocilizumab biosimilar (DRL_Tocilizumab) with tocilizumab reference product (RoActemra®) administered by the subcutaneous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis" |
| 76. Part II "A phase III, randomised, double-blind, multicentre study comparing the efficacy, safety, and immunogenicity of proposed tocilizumab biosimilar (DRL_Tocilizumab) with tocilizumab reference product (RoActemra®) administered by the subcutaneous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis" |
| 77. Part I "A 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 pMDI 200-6-12,5 µg HFA-152a, compared to CHF5993 pMDI 200-6-12,5 µg HFA-134a, in subjects with asthma," |
| 78. Part II "A 12-week double-blind, multicentre, randomised, active-controlled, 2-arm, parallel-group clinical trial to evaluate the safety of CHF5993 pMDI 200-6-12,5 µg HFA-152a, compared to CHF5993 pMDI 200-6-12,5 µg HFA-134a, in subjects with asthma," |
| 79. Part I "An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON)" |
| 80. Part II "An open-label extension trial of the long-term safety and efficacy of BI 1015550 taken orally in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) (FIBRONEER™-ON)" |
| 81. Part I "A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery-Invasive Procedure" |
| 82. Part II "A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery-Invasive Procedure" |
| 83. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis" |
| 84. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis" |
| 85. Part I "An international prospective umbrella trial for children with atypical teratoid-rhabdoid tumours (ATRT) including a randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy" |
| 86. Part II "An international prospective umbrella trial for children with atypical teratoid-rhabdoid tumours (ATRT) including a randomized phase III study evaluating the non-inferiority of three courses of high-dose chemotherapy (HDCT) compared to focal radiotherapy as consolidation therapy" |
| 87. Part I "An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients with Hematologic Malignancies Previously Enrolled in Studies with Tafasitamab" |
| 88. Part II "An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients with Hematologic Malignancies Previously Enrolled in Studies with Tafasitamab" |
| 89. Part I "A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)" |
| 90. Part II "A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)" |
| 91. Part I "A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies" |
| 92. Part II "A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in patients with chronic obstructive pulmonary disease (COPD) who participated in either EFC16750 or EFC16819 clinical studies" |
| 93. Part I "Master protocol of two independent, randomized, double-blind, Phase 3 studies comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple_x000D_ sclerosis" |
| 94. Part II "Master protocol of two independent, randomized, double-blind, Phase 3 studies comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple_x000D_ sclerosis" |
| 95. Part I "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma" |
| 96. Part II "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to evaluate Dostarlimab as Sequential Therapy after Chemoradiation in Participants with Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma" |
| 97. Part I "A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis" |
| 98. Part II "A randomised, double-blind, multicentre study comparing the efficacy, safety and immunogenicity of proposed Abatacept biosimilar (DRL_AB) with Orencia® administered by the intravenous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis" |
| 99. Part I "A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension)" |
| 100. Part II "A randomized, double-blind, placebo-controlled extension study to assess the long-term safety and tolerability of ianalumab in patients with systemic lupus erythematosus (SIRIUS-SLE extension)" |
| 101. Part I "Open-label, non-randomized, Phase 1b-2 trial investigating the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) as a part of combination therapy in participants with locally advanced and unresectable or metastatic MSI-H-dMMR gastroesophageal junction -gastric cancer" |
| 102. Part II "Open-label, non-randomized, Phase 1b-2 trial investigating the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) as a part of combination therapy in participants with locally advanced and unresectable or metastatic MSI-H-dMMR gastroesophageal junction -gastric cancer" |
| 103. Part I "An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis" |
| 104. Part II "An interventional, Phase 3 extension study to investigate long-term safety and tolerability of tolebrutinib in participants with relapsing multiple sclerosis, primary progressive multiple sclerosis, or nonrelapsing secondary progressive multiple sclerosis" |
| 105. Part I "A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction" |
| 106. Part II "A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction" |
| 107. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Cardiovascular Disease or Are at Risk for a First Cardiovascular Event" |
| 108. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Cardiovascular Disease or Are at Risk for a First Cardiovascular Event" |
| 109. Part I "A Phase 2b open-label clinical study to evaluate the tolerability and safety of an initiation dose of 5 mg of Vericiguat in participants with chronic heart failure with reduced ejection fraction," |
| 110. Part II "A Phase 2b open-label clinical study to evaluate the tolerability and safety of an initiation dose of 5 mg of Vericiguat in participants with chronic heart failure with reduced ejection fraction," |
| 111. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ,27 kg-m2 and Atherosclerotic Cardiovascular Disease and-or Chronic Kidney Disease" |
| 112. Part II A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ,27 kg-m2 |
| 113. Part I "A Phase 2-3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007)" |
| 114. Part II "A Phase 2-3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007)" |
| 115. Part I "A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients with Chronic Lymphocytic Leukemia-Small Lymphocytic Lymphoma" |
| 116. Part II "A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients with Chronic Lymphocytic Leukemia-Small Lymphocytic Lymphoma" |
| 117. Part I "An Open label, Randomized Phase 3 Study of MK 2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physicianfs Choice in Participants with HR+-HER2 Unresectable Locally Advanced or Metastatic Breast Cancer" |
| 118. Part II "An Open label, Randomized Phase 3 Study of MK 2870 as a Single Agent and in Combination with Pembrolizumab Versus Treatment of Physicianfs Choice in Participants with HR+-HER2 Unresectable Locally Advanced or Metastatic Breast Cancer" |
| 119. Part I "A multicenter, randomized, double-blind, placebocontrolled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)" |
| 120. Part II "A multicenter, randomized, double-blind, placebocontrolled, four-arm, parallel-group, dose-finding phase 2b study to investigate the safety and efficacy of TIN816 via a single intravenous infusion in the treatment of participants with sepsis-associated acute kidney injury (SA-AKI)" |
| 121. Part I "A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis" |
| 122. Part II "A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis" |
| 123. Part I "An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)" |
| 124. Part II "An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)" |
| 125. Part I "A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Crohn’s Disease (GARNET)" |
| 126. Part II "A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Crohn’s Disease (GARNET)" |
| 127. Part I "A PHASE III, RANDOMIZED, DOUBLE-BLIND STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB COMPARED WITH PLACEBO PLUS ATEZOLIZUMAB IN PARTICIPANTS WITH COMPLETELY RESECTED STAGE IIB, IIIA, OR SELECT IIIB, PD-L1 POSITIVE, NON-SMALL CELL LUNG CANCER WHO HAVE RECEIVED ADJUVANT PLATINUM-BASED CHEMOTHERAPY, (SKYSCRAPER-15)" |
| 128. Part II "A PHASE III, RANDOMIZED, DOUBLE-BLIND STUDY OF TIRAGOLUMAB PLUS ATEZOLIZUMAB COMPARED WITH PLACEBO PLUS ATEZOLIZUMAB IN PARTICIPANTS WITH COMPLETELY RESECTED STAGE IIB, IIIA, OR SELECT IIIB, PD-L1 POSITIVE, NON-SMALL CELL LUNG CANCER WHO HAVE RECEIVED ADJUVANT PLATINUM-BASED CHEMOTHERAPY, (SKYSCRAPER-15)" |
| 129. Part I "A Phase III, Randomised, Double Blind, Activecontrolled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure" |
| 130. Part II "A Phase III, Randomised, Double Blind, Activecontrolled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure" |
| 131. Part I "A Phase 3, Multi-center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy" |
| 132. Part II "A Phase 3, Multi-center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy" |
| 133. Part I "A Phase 3, Multi-center, Randomized, Open-Label Study of ABBV-383 Compared with Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)" |
| 134. Part II "A Phase 3, Multi-center, Randomized, Open-Label Study of ABBV-383 Compared with Standard Available Therapies in Subjects with Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)" |
| 135. Part I "IM027068: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis" |
| 136. Part II "IM027068: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Idiopathic Pulmonary Fibrosis" |
| 137. Part I "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction" |
| 138. Part II "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Preserved Ejection Fraction" |
| 139. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Cardiovascular Disease or Are at Risk for a First Cardiovascular Event" |
| 140. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Cardiovascular Disease or Are at Risk for a First Cardiovascular Event" |
| 141. Part I "A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)" |
| 142. Part II "A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)" |
| 143. Part I "Lowering of LDL-C with rosuvastatin or single-pill combination rosuvastatin-ezetimibe in high-very high-risk patients with hyperlipidaemia – LEASH" |
| 144. Part II "Lowering of LDL-C with rosuvastatin or single-pill combination rosuvastatin-ezetimibe in high-very high-risk patients with hyperlipidaemia – LEASH" |
| 145. Part I "A Phase I, open-label, randomized, two period, cross-over study in healthy subjects to assess the bioavailability of different formulations of deucrictibant administered as single dose under fasting condition," |
| 146. Part II "A Phase I, open-label, randomized, two period, cross-over study in healthy subjects to assess the bioavailability of different formulations of deucrictibant administered as single dose under fasting condition," |
| 147. Part I "A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk" |
| 148. Part II "A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk" |
| 149. Part I "A Phase 2, Multicenter, Randomized, Open-label, Active-Control Study of REGN7508, a Factor XI Monoclonal Antibody, for the Prevention of Venous Thromboembolism in Participants Undergoing an Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)" |
| 150. Part II "A Phase 2, Multicenter, Randomized, Open-label, Active-Control Study of REGN7508, a Factor XI Monoclonal Antibody, for the Prevention of Venous Thromboembolism in Participants Undergoing an Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)" |
| 151. Part I "A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with_x000D_ placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer" |
| 152. Part II "A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with_x000D_ placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer" |
| 153. Part I "A PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR MONOTHERAPY IN SUBJECTS WITH JAK INHIBITOR-NAĎVE MYELOFIBROSIS AND MODERATE THROMBOCYTOPENIA" |
| 154. Part II "A PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR MONOTHERAPY IN SUBJECTS WITH JAK INHIBITOR-NAĎVE MYELOFIBROSIS AND MODERATE THROMBOCYTOPENIA" |
| 155. Part I "A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease" |
| 156. Part II "A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease" |
| 157. Part I "A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3_x000D_ Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278_x000D_ in Participants with Progressive Pulmonary Fibrosis" |
| 158. Part II "A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3_x000D_ Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278_x000D_ in Participants with Progressive Pulmonary Fibrosis" |
| 159. Part I "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of mavorixafor in participants with congenital and acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and-or serious infections" |
| 160. Part II "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study of mavorixafor in participants with congenital and acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and-or serious infections" |
| 161. Part I "A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)" |
| 162. Part II "A multi-center, open-label extension study of subcutaneous secukinumab to evaluate the long-term safety and tolerability in polymyalgia rheumatica (PMR)" |
| 163. Part I "A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC , 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)" |
| 164. Part II "A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig (AZD2936) or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC , 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)" |
| 165. Part I "A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Sourced from the European Union and United States in Healthy Male Participants" |
| 166. Part II "A Randomized, Double-blind, Controlled, Parallel-group, Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® Sourced from the European Union and United States in Healthy Male Participants" |
| 167. Part I "A Phase I, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy" |
| 168. Part II "A Phase I, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy" |
| 169. Part I "A phase 3, randomised, double]blind, placebo]controlled study assessing the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin," |
| 170. Part II "A phase 3, randomised, double]blind, placebo]controlled study assessing the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin," |
| 171. Part I "A Phase 1b-2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression" |
| 172. Part II "A Phase 1b-2, multicenter, open-label platform study of select immunotherapy combinations in adult participants with previously untreated advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression" |
| 173. Part I "A Phase III, Randomised, Double-blind Study to Evaluate the Effect_x000D_ of Balcinrenone-Dapagliflozin, Compared to Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function" |
| 174. Part II "A Phase III, Randomised, Double-blind Study to Evaluate the Effect_x000D_ of Balcinrenone-Dapagliflozin, Compared to Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function" |
| 175. Part I "Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial" |
| 176. Part II "Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial" |
| 177. Part I "A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable -Metastatic Solid Tumors Who are Refractory to Available Standard Therapies" |
| 178. Part II "A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable -Metastatic Solid Tumors Who are Refractory to Available Standard Therapies" |
| 179. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State" |
| 180. Part II A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren’s Syndrome With Moderate-to-Severe Symptom State" |
| 181. Part I "A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy" |
| 182. Part II "A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy" |
| 183. Part I "A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and-or refractory diffuse large B cell lymphoma" |
| 184. Part II "A multi-center single arm Phase II study to evaluate the safety and_x000D_ efficacy of genetically engineered autologous cells expressing anti-_x000D_CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and-or refractory diffuse large B cell lymphoma" |
| 185. Part I "An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis" |
| 186. Part II "An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis" |
| 187. Part I "A Phase 2-3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)" |
| 188. Part II "A Phase 2-3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s Choice (IC) Chemotherapy in Women with Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)" |
| 189. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)" |
| 190. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)" |
| 191. Part I "A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease" |
| 192. Part II "A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease" |
| 193. Part I "A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure" |
| 194. Part II "A Phase IIb Two-Cohort, Randomised, Placebo-controlled, Double-blind, Multi-centre, Dose-ranging Study of AZD5462 in Stable Patients with Chronic Heart Failure" |
| 195. Part II "Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)" |
| 196. Part I "Phase Ib Open Label Basket Trial of RAY121 to Inhibit Classical_x000D_ Complement Pathway in Immunological Diseases (RAINBOW Trial)" |
| 197. Part II "Phase Ib Open Label Basket Trial of RAY121 to Inhibit Classical_x000D_ Complement Pathway in Immunological Diseases (RAINBOW Trial)" |
| 198. Part I "An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Participants Over 18 Years of Age with Hormone Receptor-Positive, HER2-Negative Advanced-Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4-6 Inhibitor-based Therapy" |
| 199. Part II "An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Participants Over 18 Years of Age with Hormone Receptor-Positive, HER2-Negative Advanced-Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4-6 Inhibitor-based Therapy" |
| 200. Part I "A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants with Previously Untreated Advanced Melanoma (PRISM-MEL-301)" |
| 201. Part II "A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants with Previously Untreated Advanced Melanoma (PRISM-MEL-301)" |
| 202. Part I "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy" |
| 203. Part II "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy" |
| 204. Part I "Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies" |
| 205. Part II "Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies" |
| 206. Part I "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)" |
| 207. Part II "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants with Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)" |
| 208. Part I "A Phase 3, randomized, double-blind, study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy" |
| 209. Part II "A Phase 3, randomized, double-blind, study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy" |
| 210. Part I "A randomized, double-blind, parallel-group study to compare pharmacokinetics, efficacy, safety, and immunogenicity of JPB898 (proposed nivolumab biosimilar) and US-licensed and EU-authorized Opdivo® in combination with Yervoy® in participants with untreated advanced (unresectable-metastatic) melanoma" |
| 211. Part II "A randomized, double-blind, parallel-group study to compare pharmacokinetics, efficacy, safety, and immunogenicity of JPB898 (proposed nivolumab biosimilar) and US-licensed and EU-authorized Opdivo® in combination with Yervoy® in participants with untreated advanced (unresectable-metastatic) melanoma" |
| 212. Part I "Safety and efficacy of once-weekly subcutaneous and once-daily oral NNC0487-0111 in participants with type 2 diabetes – a dose finding study" |
| 213. Part II "Safety and efficacy of once-weekly subcutaneous and once-daily oral NNC0487-0111 in participants with type 2 diabetes – a dose finding study" |
| 214. Part I "A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs, Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing" |
| 215. Part II "A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs, Placebo given in Children Aged 6 Months to 5 Years with Recurrent Wheezing" |
| 216. Part I "A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over_x000D_ Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment_x000D_ of Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 217. Part II "A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over_x000D_ Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment_x000D_ of Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 218. Part I "A phase II, multi-site, open-label, dose-titration trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of Lu AG13909 in adults with Cushing’s disease" |
| 219. Part II "A phase II, multi-site, open-label, dose-titration trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of Lu AG13909 in adults with Cushing’s disease" |
| 220. Part I "A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure" |
| 221. Part II "A multi-center, randomized, placebo- and active-controlled, parallel-group, 24-week proof of concept and dose-finding study to evaluate efficacy, safety, and tolerability of XXB750 in patients with heart failure" |
| 222. Part I "A multicenter, randomized, parallel-group, double-blind, active-controlled study to evaluate the efficacy and safety of bimekizumab compared to ustekinumab in children and adolescents from 6 years to less than 18 years of age with moderate to severe plaque psoriasis" |
| 223. Part II "A multicenter, randomized, parallel-group, double-blind, active-controlled study to evaluate the efficacy and safety of bimekizumab compared to ustekinumab in children and adolescents from 6 years to less than 18 years of age with moderate to severe plaque psoriasis" |
| 224. Part I "A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT" |
| 225. Part II "A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT" |
| 226. Part I "A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis" |
| 227. Part II "A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis" |
| 228. Part I "A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma" |
| 229. Part II "A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma" |
| 230. Part I A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS 1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)_x000D__x000D_ |
| 231. Part II A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS 1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) |
| 232. Part I "Interventional, randomized, double-blind, parallel-group, placebocontrolled, dose-finding trial of Lu AG09222 for the prevention of migraine in participants with unsuccessful prior preventive treatments" |
| 233. Part II "Interventional, randomized, double-blind, parallel-group, placebocontrolled, dose-finding trial of Lu AG09222 for the prevention of migraine in participants with unsuccessful prior preventive treatments" |
| 234. Part I "A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib-Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants with Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT trial)" |
| 235. Part II "A Placebo-controlled, Double-blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib-Ezetimibe Fixed Dose Combination Daily on Coronary Plaque Characteristics in Participants with Atherosclerotic Cardiovascular Disease on Coronary CT Angiography (REMBRANDT trial)" |
| 236. Part I "A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis" |
| 237. Part II "A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis" |
| 238. Part I "A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis" |
| 239. Part II "A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Induction Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Ulcerative Colitis" |
| 240. Part I "A Phase 2-3 Multicenter, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 241. Part II "A Phase 2-3 Multicenter, Randomized, Double-Blind, Placebo Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 242. Part I "Examination of the incidence of postoperative residual neuromuscular blockade after muscle relaxation with rocuronium in thoracic surgery patients: a randomized placebo-controlled study" |
| 243. Part II "Examination of the incidence of postoperative residual neuromuscular blockade after muscle relaxation with rocuronium in thoracic surgery patients: a randomized placebo-controlled study" |
| 244. Part I "A phase 2 randomized, placebo-controlled, double-masked, dose finding study to investigate the efficacy and safety of BAY 3283142 in patients with moderately severe to severe non-proliferative diabetic retinopathy (ARGON-NPDR)" |
| 245. Part I "A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-selected non-small-cell lung cancer (GALAXIES LUNG-301)" |
| 246. Part II "A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-selected non-small-cell lung cancer (GALAXIES LUNG-301)" |
| 247. Part I "A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission," |
| 248. Part II "A randomised, double-blind, double-dummy, multicentre, phase III, non inferiority trial of an oral mesalazine formulation in patients with active mild to moderate ulcerative colitis for the induction of remission," |
| 249. Part I "Phase 3 Multicenter, Randomized, Open-label, Activecontrolled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naďve Subjects With Metastatic Clorectal Cancer With KRAS p,G12C Mutation (CodeBreaK 301)" |
| 250. Part II "Phase 3 Multicenter, Randomized, Open-label, Activecontrolled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naďve Subjects With Metastatic Colorectal Cancer With KRAS p,G12C Mutation (CodeBreaK 301)" |
| 251. Part I "An open-label study for participants who are non-responders at the end of treatment assessment on the VRDN-001-101 and VRDN-001-301 pivotal studies" |
| 252. Part II "An open-label study for participants who are non-responders at the end of treatment assessment on the VRDN-001-101 and VRDN-001-301 pivotal studies" |
| 253. Part I "A randomized, double-blind, placebo-controlled, 2-cohort, Phase 3 study to assess the efficacy and safety of riliprubart in adult participants with cold agglutinin disease (CAD)" |
| 254. Part II "A randomized, double-blind, placebo-controlled, 2-cohort, Phase 3 study to assess the efficacy and safety of riliprubart in adult participants with cold agglutinin disease (CAD)" |
| 255. Part I "Open-Label Extension study to assess the long-term safety and tolerability of KarXT in subjects with Psychosis Associated with Alzheimer’s Disease" |
| 256. Part II "Open-Label Extension study to assess the long-term safety and tolerability of KarXT in subjects with Psychosis Associated with Alzheimer’s Disease" |
| 257. Part I "A Phase 3 Study of Pembrolizumab in Combination With Carboplatin-Taxane (Paclitaxel or Nab-paclitaxel) followed by_x000D_ Pembrolizumab With or Without Maintenance MK-2870 in the Firstline Treatment of Metastatic Squamous Non-small Cell Lung Cancer" |
| 258. Part II "A Phase 3 Study of Pembrolizumab in Combination With Carboplatin-Taxane (Paclitaxel or Nab-paclitaxel) followed by_x000D_ Pembrolizumab With or Without Maintenance MK-2870 in the Firstline Treatment of Metastatic Squamous Non-small Cell Lung Cancer" |
| 259. Part I "A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)" |
| 260. Part II "A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)" |
| 261. "RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)" |
| 262. "RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)" |
| 263. Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1,0 mg-1,0 mg s,c, once weekly versus tirzepatide 5 mg s,c, once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both |
| 264. Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) 1,0 mg-1,0 mg s,c, once weekly versus tirzepatide 5 mg s,c, once weekly in participants with type 2 diabetes inadequately controlled on metformin, SGLT2 inhibitor or both |
| 265. "A study to learn about the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with diabetic macular edema or neovascular age-related macular degeneration" |
| 266. "A study to learn about the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with diabetic macular edema or neovascular age-related macular degeneration" |
| 267. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered ALN-APP in Patients with Cerebral Amyloid Angiopathy (CAA) |
| 268. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered ALN-APP in Patients with Cerebral Amyloid Angiopathy (CAA) |
| 269. Part I "A Phase 2a, Randomized, Placebo-Controlled, Double Blind Multiple Ascending Dose Study in Patients with Cystic Fibrosis Carrying the 3849 +10 Kb C->T Mutation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Effi-cacy of SPL84" |
| 270. Part II "A Phase 2a, Randomized, Placebo-Controlled, Double Blind Multiple Ascending Dose Study in Patients with Cystic Fibrosis Carrying the 3849 +10 Kb C->T Mutation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Effi-cacy of SPL84" |
| 271. Part I "A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia" |
| 272. Part II "A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia" |
| 273. Part I "A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines" |
| 274. Part II "A 52-week multi-center, randomized, double-blind, placebo controlled, basket study with an open-label extension to investigate the efficacy, safety, and tolerability of remibrutinib (LOU064) in Chronic Inducible Urticaria (CINDU) in adults inadequately controlled by H1-antihistamines" |
| 275. Part I "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 276. Part II "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 277. Part I "A Phase IIa-IIb, randomised, double blind, placebocontrolled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough" |
| 278. Part II "A Phase IIa-IIb, randomised, double blind, placebocontrolled, parallel-group dose-finding study to examine the efficacy and safety of BI 1839100 administered orally over a 12-week treatment period in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis with clinically meaningful cough" |
| 279. Part I "A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma" |
| 280. Part II "A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma" |
| 281. Part I A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02) |
| 282. Part II A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician’s Choice (TPC) in Subjects with Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02) |
| 283. Part I "A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis" |
| 284. Part II "A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis" |
| 285. Part I "A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma" |
| 286. Part II "A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma" |
| 287. Part I "A Phase 1-Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies" |
| 288. Part II "A Phase 1-Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants with Hematologic Malignancies" |
| 289. Part I "A randomized, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to Immune Checkpoint Inhibitor (ICI) - ARTEMIA study" |
| 290. Part II "A randomized, open-label, phase 3 trial comparing the efficacy and safety of OSE2101 versus docetaxel in HLA-A2 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to Immune Checkpoint Inhibitor (ICI) - ARTEMIA study" |
| 291. Part I "A randomised, double-blind, placebo-controlled, dosefinding study evaluating efficacy, safety, and tolerability of different oral doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF)" |
| 292. Part II "A randomised, double-blind, placebo-controlled, dosefinding study evaluating efficacy, safety, and tolerability of different oral doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF)" |
| 293. Part I "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa," |
| 294. Part II "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa," |
| 295. Part I "A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2-3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma" |
| 296. Part I "A Randomized, Double-blind, Placebo controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Subjects With Antineutrophil Cytoplasmic Antibody (ANCA) associated Vasculitis" |
| 297. Part II "A Randomized, Double-blind, Placebo controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Subjects With Antineutrophil Cytoplasmic Antibody (ANCA) associated Vasculitis" |
| 298. Part I "A randomized, two-period crossover study to demonstrate the comparability of pharmacokinetics of subcutaneous ianalumab between 2mL auto-injector-2mL pre-filled syringe with 1 mL pre-filled syringe in adult participants with autoimmune disease" |
| 299. Part II "A randomized, two-period crossover study to demonstrate the comparability of pharmacokinetics of subcutaneous ianalumab between 2mL auto-injector-2mL pre-filled syringe with 1 mL pre-filled syringe in adult participants with autoimmune disease" |
| 300. Part I "KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)" |
| 301. Part II "KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)" |
| 302. Part I "A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib"_x000D_ |
| 303. Part II "A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib" |
| 304. Part I "A randomized, double-blind, placebo-controlled, Phase 2 study to assess the efficacy, safety, and pharmacokinetics of FNP-223 (oral formulation) to slow the disease progression of progressive supranuclear palsy (PSP) (PROSPER)" |
| 305. Part II "A randomized, double-blind, placebo-controlled, Phase 2 study to assess the efficacy, safety, and pharmacokinetics of FNP-223 (oral formulation) to slow the disease progression of progressive supranuclear palsy (PSP) (PROSPER)" |
| 306. Part I "EASi-HF , A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF),40%" |
| 307. Part II "EASi-HF , A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF),40%" |
| 308. Part I "A Phase 2-3, Multicenter, Open label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy" |
| 309. Part II "A Phase 2-3, Multicenter, Open label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy" |
| 310. Part I "A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE" |
| 311. Part II "A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF ASTEGOLIMAB IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE" |
| 312. Part I "A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA-associated vasculitis" |
| 313. Part II "A randomized, controlled study to evaluate LNP023 (iptacopan) in patients with active ANCA-associated vasculitis" |
| 314. Part I "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-4 Study)" |
| 315. Part II "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-4 Study)" |
| 316. Part I "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-3 Study)" |
| 317. Part II "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-3 Study)" |
| 318. Part I "A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and Keytruda® (Pembrolizumab) in Subjects with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer" |
| 319. Part II "A Randomized, Double-Blind Study to Compare Efficacy, Pharmacokinetics, Safety, and Immunogenicity Between ABP 234 and_x000D_ Keytruda® (Pembrolizumab) in Subjects with Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer" |
| 320. Part I "A Randomized, Open-Label Phase 2-3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer" |
| 321. Part II "A Randomized, Open-Label Phase 2-3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer" |
| 322. Part I "The ENERGY 2 Study: An Open-Label Phase 3 Study to Evaluate the Efficacy and Safety of INZ-701 in Infants with Ectonucleotide Pyrophosphatase-Phosphodiesterase 1 (ENPP1) Deficiency" |
| 323. Part II "The ENERGY 2 Study: An Open-Label Phase 3 Study to Evaluate the Efficacy and Safety of INZ-701 in Infants with Ectonucleotide Pyrophosphatase-Phosphodiesterase 1 (ENPP1) Deficiency" |
| 324. Part I “A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia” |
| 325. Part I "A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4-6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+- ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)" |
| 326. Part II "A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant compared with Physician’s Choice CDK4-6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients with BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor-Positive, HER2-Negative (IHC 0, 1+, 2+- ISH non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)" |
| 327. Part I "A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) versus Hydroxyurea in Cytoreductive Therapy Naive Essential Thrombocythemia Participants" |
| 328. Part II "A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) versus Hydroxyurea in Cytoreductive Therapy Naive Essential Thrombocythemia Participants" |
| 329. Part I "A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations," |
| 330. Part II "A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2-activating mutations," |
| 331. Part I "A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis" |
| 332. Part II "A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis" |
| 333. Part I "MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)" |
| 334. Part II "MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)" |
| 335. Part I "ReNEW: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects who have Dry Age-Related Macular Degeneration (Dry AMD)" |
| 336. Part II "ReNEW: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects who have Dry Age-Related Macular Degeneration (Dry AMD)" |
| 337. Part I "A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease" |
| 338. Part II "A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease" |
| 339. Part I "A PHASE III, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH MODERATE TO SEVERE THYROID EYE DISEASE" |
| 340. Part II "A PHASE III, RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH MODERATE TO SEVERE THYROID EYE DISEASE" |
| 341. Part I "A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV- 7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 342. Part II "A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV- 7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 343. Part I "A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants with Sjögren’s Syndrome" |
| 344. Part II "A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants with Sjögren’s Syndrome" |
| 345. Part I "A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION" |
| 346. Part II "A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF VE303 FOR PREVENTION OF RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION" |
| 347. Part I "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the_x000D_ Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with_x000D_ Cataplexy (Narcolepsy Type 1)" |
| 348. Part II "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the_x000D_ Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with_x000D_ Cataplexy (Narcolepsy Type 1)" |
| 349. Part I "CRIMSON: A multicentre, randomised, sham-controlled (and active controlled in the USA), double-masked, 72-week trial to study the safety, tolerability, pharmacokinetics, and efficacy of 3 dosing regimens of intravitreal BI 764524 in patients with moderately severe to severe non-proliferative diabetic retinopathy" |
| 350. Part II "CRIMSON: A multicentre, randomised, sham-controlled (and active controlled in the USA), double-masked, 72-week trial to study the safety, tolerability, pharmacokinetics, and efficacy of 3 dosing regimens of intravitreal BI 764524 in patients with moderately severe to severe non-proliferative diabetic retinopathy" |
| 351. Part I "A pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of allo-APZ2-CVU on wound healing of therapy-resistant non-healing chronic venous ulcers (CVU)" |
| 352. Part II "A pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of allo-APZ2-CVU on wound healing of therapy-resistant non-healing chronic venous ulcers (CVU)" |
| 353. Part I "A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients with Moderate to Severe Crohn´s Disease (Amalthea)" |
| 354. Part II "A Double-blind, Placebo-controlled Phase IIa Study to Evaluate the Efficacy and Safety of AZD7798 in Patients with Moderate to Severe Crohn´s Disease (Amalthea)" |
| 355. Part I "A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women with Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy" |
| 356. Part II "A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women with Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy" |
| 357. Part I "Measuring of the duration of action of different doses of rocuronium-induced neuromuscular block in infants during surgical treatment of craniosynostosis - a prospective, case-controlled study" |
| 358. Part II "Measuring of the duration of action of different doses of rocuronium-induced neuromuscular block in infants during surgical treatment of craniosynostosis - a prospective, case-controlled study" |
| 359. Part I "A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)" |
| 360. Part II "A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)" |
| 361. Part I "A Phase 3, 52-Week, Multicenter, Randomized, Placebocontrolled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical" |
| 362. Part II "A Phase 3, 52-Week, Multicenter, Randomized, Placebocontrolled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies or Not Eligible for Topical" |
| 363. Part I "DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PLOZASIRAN IN_x000D_ ADULTS WITH HYPERTRIGLYCERIDEMIA (MUIR-3 STUDY)" |
| 364. Part II "DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PLOZASIRAN IN ADULTS WITH HYPERTRIGLYCERIDEMIA (MUIR-3 STUDY)" |
| 365. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease" |
| 366. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease" |
| 367. Part I "Efficacy And Tolerability of ODM-111 in Chronic Pain due to Diabetic Peripheral Neuropathy" |
| 368. Part II "Efficacy And Tolerability of ODM-111 in Chronic Pain due to Diabetic Peripheral Neuropathy" |
| 369. Part I "AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE" |
| 370. Part II "AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE" |
| 371. Part I "A randomized, double-blind, parallel group, placebocontrolled multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis" |
| 372. Part II "A randomized, double-blind, parallel group, placebocontrolled_x000D_ multicenter study to evaluate efficacy, safety and tolerability of ianalumab in participants with diffuse cutaneous systemic sclerosis" |
| 373. Part I "A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less Than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)" |
| 374. Part II "A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less Than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)" |
| 375. Part I "A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis" |
| 376. Part II "A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis" |
| 377. Part I "Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis" |
| 378. Part II "Randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to teriflunomide in adult participants with relapsing forms of multiple sclerosis" |
| 379. Part I "A Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Active Comparator (Apremilast)-controlled Phase 3 Study to Evaluate the Efficacy and Safety of ME3183 in Subjects with Moderate to Severe Plaque Psoriasis (BRING-1 Study)" |
| 380. Part II "A Multicenter, Randomized, Double-blind, Double-dummy, Placebo- and Active Comparator (Apremilast)-controlled Phase 3 Study to Evaluate the Efficacy and Safety of ME3183 in Subjects with Moderate to Severe Plaque Psoriasis (BRING-1 Study)" |
| 381. Part I "A Phase II, single-arm, open-label, long-term safety rollover trial of oral brigimadlin in patients with solid tumours Clinical Trial Application - Initial submission of trial 1403-0032 according to Article 5 of Regulation (EU) No 536-2014" |
| 382. Part II "A Phase II, single-arm, open-label, long-term safety rollover trial of oral brigimadlin in patients with solid tumours Clinical Trial Application - Initial submission of trial 1403-0032 according to Article 5 of Regulation (EU) No 536-2014" |
| 383. Part I "A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa" |
| 384. Part II "A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa" |
| 385. Part I "A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2-3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0,5mg) in Participants with Diabetic Macular Edema" |
| 386. Part II "A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2-3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0,5mg) in Participants with Diabetic Macular Edema" |
| 387. Part I "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" |
| 388. Part II "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" |
| 389. Part I "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" |
| 390. Part II "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS" |
| 391. Part I "A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Subjects With Type 2 Diabetes Mellitus" |
| 392. Part II "A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Subjects With Type 2 Diabetes Mellitus" |
| 393. Part I "A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn´s Disease" |
| 394. Part II "A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn´s Disease" |
| 395. Part I "Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality" |
| 396. Part II "Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver_x000D_ Failure" (ACLF) at High Risk of Hospital Mortality" |
| 397. Part I "A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open-label Long-term Extension Treatment with Aticaprant" |
| 398. Part II "A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants with Major Depressive Disorder (MDD) with Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy and an Open-label Long-term Extension Treatment with Aticaprant" |
| 399. Part I "A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 3018250 in patients with symptomatic proximal deep vein thrombosis" |
| 400. Part II "A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of BAY 3018250 in patients with_x000D_ symptomatic proximal deep vein thrombosis" |
| 401. Part I „Assessing the efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients in a double-blind, randomized, placebo-controlled trial: the EXOTIC trial” |
| 402. Part II „Assessing the efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients in a double-blind, randomized, placebo-controlled trial: the EXOTIC trial” |
| 403. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER)" |
| 404. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER)" |
| 405. Part I "Long-term Extension Study for Participants with Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies" |
| 406. Part II "Long-term Extension Study for Participants with Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies" |
| 407. Part I "A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)" |
| 408. Part II "A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)" |
| 409. Part I "A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0,1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis" |
| 410. Part II "A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0,1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis" |
| 411. Part I "A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUNCTIVE RECOMBINANT HUMAN PLASMA GELSOLIN WITH STANDARD OF CARE FOR MODERATE-TO-SEVERE ARDS DUE TO PNEUMONIA OR OTHER INFECTIONS" |
| 412. Part II "A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ADJUNCTIVE RECOMBINANT HUMAN PLASMA GELSOLIN WITH STANDARD OF CARE FOR MODERATE-TO-SEVERE ARDS DUE TO PNEUMONIA OR OTHER INFECTIONS" |
| 413. Part I "A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants with Episodic Migraine" |
| 414. Part II "A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants with Episodic Migraine" |
| 415. Part I "A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients with Moderate-to-severe Atopic Dermatitis" |
| 416. Part II "A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients with Moderate-to-severe Atopic Dermatitis" |
| 417. Part I "A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus" |
| 418. Part II "A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults with Type 2 Diabetes Mellitus" |
| 419. Part I "A multicenter, randomized open-label study to assess the efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in subjects from 1 year to less than 18 years old with active systemic juvenile idiopathic arthritis," |
| 420. Part II "A multicenter, randomized open-label study to assess the efficacy, safety, and pharmacokinetics of upadacitinib with a tocilizumab reference arm in subjects from 1 year to less than 18 years old with active systemic juvenile idiopathic arthritis," |
| 421. Part I "A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, RISANKIZUMAB-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN ADULT STUDY PARTICIPANTS WITH ACTIVE PSORIATIC ARTHRITIS" |
| 422. Part II "A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, RISANKIZUMAB-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN ADULT STUDY PARTICIPANTS WITH ACTIVE PSORIATIC ARTHRITIS" |
| 423. Part I "A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU2)" |
| 424. Part II "A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ – CSU2)" |
| 425. Part I "A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis" |
| 426. Part II "A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis" |
| 427. Part I "A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care," |
| 428. Part II "A Phase 2, Multicenter, Single-blinded, Randomized Study to Evaluate the Pharmacokinetics and Safety of Sotatercept (MK-7962) Administered Using Either a Weight-based or Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care," |
| 429. Part I "A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease" |
| 430. Part II "A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögren’s Disease" |
| 431. Part I "A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)" |
| 432. Part II "A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)" |
| 433. Part I "A parallel-group treatment, Phase 2a, multicenter, randomized, double-blind, placebocontrolled umbrella study to evaluate the efficacy and safety of frexalimab, SAR442970, and rilzabrutinib in male and female participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)" |
| 434. Part II "A parallel-group treatment, Phase 2a, multicenter, randomized, double-blind, placebocontrolled umbrella study to evaluate the efficacy and safety of frexalimab, SAR442970, and rilzabrutinib in male and female participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)" |
| 435. Part I "A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]-BMS-986504 (MRTX1719) in Patients with Advanced Solid Tumors with Homozygous MTAP Deletion" |
| 436. Part II "A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]-BMS-986504 (MRTX1719) in Patients with Advanced Solid Tumors with Homozygous MTAP Deletion" |
| 437. Part I "A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS-NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)" |
| 438. Part II "A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS-NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (OrigAMI-2)" |
| 439. Part I "A phase 2b, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of obefazimod in subjects with moderately to severely active Crohn’s disease," |
| 440. Part II "A phase 2b, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of obefazimod in subjects with moderately to severely active Crohn’s disease," |
| 441. Part I "A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)" |
| 442. Part II "A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)" |
| 443. Part I "An Adaptive Phase 2a-2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis" |
| 444. Part II "An Adaptive Phase 2a-2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis" |
| 445. Part I "A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab-Bevacizumab + FOLFIRI in Participants With KRAS-NRAS and BRAF Wildtype Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy (OrigAMI-3)" |
| 446. Part II "A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab-Bevacizumab + FOLFIRI in Participants With KRAS-NRAS and BRAF Wildtype Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy (OrigAMI-3)" |
| 447. Part I "A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)" |
| 448. Part II "A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)" |
| 449. Part I "A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated nonalcoholic steatohepatitis-metabolic dysfunction associated steatohepatitis (NASH-MASH) cirrhosis" |
| 450. Part II "A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated nonalcoholic steatohepatitis-metabolic dysfunction associated steatohepatitis (NASH-MASH) cirrhosis" |
| 451. Part I "A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis-metabolic associated steatohepatitis (NASH-MASH) and (F2) - (F3) stage of liver fibrosis" |
| 452. Part II "A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis-metabolic associated steatohepatitis (NASH-MASH) and (F2) - (F3) stage of liver fibrosis" |
| 453. Part I "A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis" |
| 454. Part II "A Phase 3, Multicenter, Open-Label Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis" |
| 455. Part II “A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia” |
| 456. Part I "A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)" |
| 457. Part II "A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)" |
| 458. Part I "A Phase 3, Open,label, Uncontrolled Single,arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children from 6 Years to < 18 Years of Age with Active ANCA-associated Vasculitis (AAV)," |
| 459. Part II "A Phase 3, Open,label, Uncontrolled Single,arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With a Rituximab or a Cyclophosphamide-containing Regimen in Children from 6 Years to < 18 Years of Age with Active ANCA-associated Vasculitis (AAV)," |
| 460. Part I "A Phase 2, adaptive, double-blinded, placebo-controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy" |
| 461. Part II "A Phase 2, adaptive, double-blinded, placebo-controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy" |
| 462. Part II "A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2-3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants with Advanced Melanoma" |
| 463. Part I "A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)" |
| 464. Part II "A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)" |
| 465. Part I "A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)" |
| 466. Part II "A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator Controlled Phase 3 Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (ONWARD2)" |
| 467. Part I "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis" |
| 468. Part II "A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of LY4100511 (DC-853) for the Treatment of Adult Participants with Moderate-to-Severe Plaque Psoriasis" |
| 469. Part I "A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1-PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)" |
| 470. Part II "A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1-PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)" |
| 471. Part I "A Phase 2-3 Long-term Extension Basket Clinical Study to Evaluate the Safety and Efficacy of Tulisokibart (MK-7240) in Participants With Moderately or Severely Active Crohn´s Disease or Ulcerative Colitis" |
| 472. Part II "A Phase 2-3 Long-term Extension Basket Clinical Study to Evaluate the Safety and Efficacy of Tulisokibart (MK-7240) in Participants With Moderately or Severely Active Crohn´s Disease or Ulcerative Colitis" |
| 473. Part I "A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial Onset Seizures" |
| 474. Part II "A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial Onset Seizures" |
| 475. Part I "A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)" |
| 476. Part II "A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)" |
| 477. Part I "A Phase I, Open-Label, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Influence of a High-Calorie, High-Fat Meal on the Bioavailability of a 40 mg Extended-Release (XR) Deucrictibant Oral Formulation Administered as a Single Dose," |
| 478. Part II "A Phase I, Open-Label, Randomized, Two-Period, Cross-Over Study in Healthy Subjects to Assess the Influence of a High-Calorie, High-Fat Meal on the Bioavailability of a 40 mg Extended-Release (XR) Deucrictibant Oral Formulation Administered as a Single Dose," |
| 479. Part I "A Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease," |
| 480. Part II "A Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease," |
| 481. Part I "A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults" |
| 482. Part II "A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults" |
| 483. Part I "A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults" |
| 484. Part II "A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults" |
| 485. Part I "Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability and efficacy of inclisiran in children (6 to less than 12 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-20)" |
| 486. Part II "Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability and efficacy of inclisiran in children (6 to less than 12 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-20)" |
| 487. Part I "A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 488. Part II "A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 489. Part I "A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Established Atherosclerotic Cardiovascular and Chronic Kidney Disease" |
| 490. Part II "A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Established Atherosclerotic Cardiovascular and Chronic Kidney Disease" |
| 491. Part I "A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive With Moderate to Severe Active Ulcerative Colitis" |
| 492. Part II "A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive With Moderate to Severe Active Ulcerative Colitis" |
| 493. Part I "Phase IB open label, long-term, extension basket trial of RAY121 to inhibit classical complement pathway in immunological diseases (RAINBOW-LTE trial)" |
| 494. Part II "Phase IB open label, long-term, extension basket trial of RAY121 to inhibit classical complement pathway in immunological diseases (RAINBOW-LTE trial)" |
| 495. Part I "A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)" |
| 496. Part II "A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)" |
| 497. Part I "An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis" |
| 498. Part II "An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis" |
| 499. Part I "A Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Effects of NTRX-07 in Sub-jects with Mild Cognitive Impairment MCI) or Mild to Moderate Alzheimer’s Disease (AD) (SPPN-AD)" |
| 500. Part II "A Multicenter, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Effects of NTRX-07 in Sub-jects with Mild Cognitive Impairment MCI) or Mild to Moderate Alzheimer’s Disease (AD) (SPPN-AD)" |
| 501. Part I "A Double-Blind, Randomized, Placebo and Active Controlled Study to Evaluate the Efficacy and Safety of Once Daily, Extended Release Levetiracetam as Add-on Therapy in Patients with Refractory Partial Onset Epilepsy" |
| 502. Part II "A Double-Blind, Randomized, Placebo and Active Controlled Study to Evaluate the Efficacy and Safety of Once Daily, Extended Release Levetiracetam as Add-on Therapy in Patients with Refractory Partial Onset Epilepsy" |
| 503. Part I "A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)" |
| 504. Part II "A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age Related Macular Degeneration (AMD)" |
| 505. Part I "A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with active thyroid eye disease (TED)" |
| 506. Part II "A phase 3, randomized, double-masked, placebo-controlled, efficacy, safety, and tolerability study of VRDN-003 in participants with active thyroid eye disease (TED)" |
| 507. Part I "A phase 3, randomized, double-masked, placebo-controlled, efficacy,_x000D_ safety, and tolerability study of VRDN-003 in participants with chronic_x000D_ thyroid eye disease (TED)" |
| 508. Part II "A phase 3, randomized, double-masked, placebo-controlled, efficacy,_x000D_ safety, and tolerability study of VRDN-003 in participants with chronic thyroid eye disease (TED)" |
| 509. Part I "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 510. Part II "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 511. Part I "A Phase 2, Open-label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants with Relapsed or Refractory Chronic Lymphocytic Leukemia-Small Lymphocytic Lymphoma (CLL-SLL) Who Previously Received Treatment with a Covalent Bruton Tyrosine Kinase Inhibitor" |
| 512. Part II "A Phase 2, Open-label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants with Relapsed or Refractory Chronic Lymphocytic Leukemia-Small Lymphocytic Lymphoma (CLL-SLL) Who Previously Received Treatment with a Covalent Bruton Tyrosine Kinase Inhibitor" |
| 513. Part I "A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration" |
| 514. Part II "A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Participants with Geographic Atrophy Secondary to Age-Related Macular Degeneration" |
| 515. Part I "A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)" |
| 516. Part II "A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)" |
| 517. Part I "A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis" |
| 518. Part II "A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis" |
| 519. Part I "A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)" |
| 520. Part II "A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)" |
| 521. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis" |
| 522. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3- Arm, 3-Period Study to Assess the Efficacy and Safety of a New Formulation of Oral Cladribine Compared with Placebo in Participants with Generalized Myasthenia Gravis" |
| 523. Part I "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine" |
| 524. Part II "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine" |
| 525. Part I "A Phase 3 Randomized, Double-Masked, Active-Controlled Study of the_x000D_ Efficacy and Safety of 8 mg Aflibercept in Participants With Macular_x000D_ Edema Following Retinal Vein Occlusion" |
| 526. Part II "A Phase 3 Randomized, Double-Masked, Active-Controlled Study of the_x000D_ Efficacy and Safety of 8 mg Aflibercept in Participants With Macular_x000D_ Edema Following Retinal Vein Occlusion" |
| 527. Part I "A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adult Participants with Chronic Rhinosinusitis with Nasal Polyposis Initiating Treatment with Tezepelumab (ESSENCE)" |
| 528. Part II "A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adult Participants with Chronic Rhinosinusitis with Nasal Polyposis Initiating Treatment with Tezepelumab (ESSENCE)" |
| 529. Part I "A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis" |
| 530. Part II "A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis" |
| 531. Part I "A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 532. Part II "A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema" |
| 533. Part I "A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)" |
| 534. Part II "A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)" |
| 535. Part I "LIGHTBEAM-U01 Master Protocol: A Phase 1-2 Platform Study to Evaluate the Safety and Efficacy of Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors," _x000D_ LIGHTBEAM-U01 Substudy 01B: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors |
| 536. Part II "LIGHTBEAM-U01 Master Protocol: A Phase 1-2 Platform Study to Evaluate the Safety and Efficacy of Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors,"_x000D_ LIGHTBEAM-U01 Substudy 01B: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Pembrolizumab in Combination with Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors |
| 537. Part I "Elacestrant versus Standard Endocrine Therapy in Women and Men with Nodepositive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)" |
| 538. Part II "Elacestrant versus Standard Endocrine Therapy in Women and Men with Nodepositive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)" |
| 539. Part I "A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors" |
| 540. Part II "A Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm, to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis and previous inadequate response or intolerance to tumor necrosis factor-α inhibitors" |
| 541. Part I "A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who are naive to biologic DMARDs," |
| 542. Part II "A Phase 3, parallel-group, randomized, double-blind, 3-arm, placebo-controlled, multicenter study to investigate the efficacy and safety of subcutaneous sonelokimab in male and female participants aged 18 years and over with active psoriatic arthritis who are naive to biologic DMARDs," |
| 543. Part I "A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY" |
| 544. Part II "A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY OF PF-07976016 TO ASSESS SAFETY AND EFFICACY IN ADULT PARTICIPANTS WITH OBESITY" |
| 545. Part I "A Phase 2, adaptive, randomized, open-label, assessor-blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythemarosus (SLE) with active, refractory lupus nephritis (LN)" |
| 546. Part II "A Phase 2, adaptive, randomized, open-label, assessor-blinded active-controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus Standard of Care in patients suffering from systemic lupus erythemarosus (SLE) with active, refractory lupus nephritis (LN)" |
| 547. Part I "A Phase II, multi-part, three-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis" |
| 548. Part II "A Phase II, multi-part, three-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis" |
| 549. Part I "An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment" |
| 550. Part II "An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment" |
| 551. Part I "TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced-metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy," |
| 552. Part II "TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced-metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (PD-1 antagonist) and chemotherapy," |
| 553. Part I "A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients with Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia (QuANTUM-Wild) (Quizartinib or placebo plus chemotherapy in newly diagnosed patients with FLT3-ITD negative AML)" |
| 554. Part II "A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial of Quizartinib Administered in Combination with Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients with Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia (QuANTUM-Wild) (Quizartinib or placebo plus chemotherapy in newly diagnosed patients with FLT3-ITD negative AML)" |
Módosítási kérelmek száma 2024-ben: 1754
2025
| Sorszám és cím |
|---|
| 1. Part I "A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies" |
| 2. Part II "A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies" |
| 3. Part I "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 4. Part II "Individualized everolimus therapy in metastatic breast cancer phase 2, non-commercial clinical trial" |
| 5. Part I "A randomized, Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to investigate the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult_x000D_ participants with high-risk asthma who are not currently eligible for biologic treatment" |
| 6. Part II "A randomized, Phase 2, double-blind, placebo-controlled, parallel-group, 2-arm study to investigate the efficacy, safety, and tolerability of subcutaneous lunsekimig (SAR443765) in adult participants with high-risk asthma who are not currently eligible for biologic treatment" |
| 7. Part I "A Phase 2a, open-label, randomized, controlled, multi-center, proof of concept study, to assess the efficacy, safety and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF) grade 1 and 2 and ascites (UNVEIL-IT®)" |
| 8. Part II "A Phase 2a, open-label, randomized, controlled, multi-center, proof of concept study, to assess the efficacy, safety and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF) grade 1 and 2 and ascites (UNVEIL-IT®)" |
| 9. Part I "An open-label extension study to assess the efficacy and safety of ianalumab with or without study treatment withdrawal in adult participants with lupus nephritis who have completed study treatment in the CVAY736K12301 core study (SIRIUS-LN extension)" |
| 10. Part II "An open-label extension study to assess the efficacy and safety of ianalumab with or without study treatment withdrawal in adult participants with lupus nephritis who have completed study treatment in the CVAY736K12301 core study (SIRIUS-LN extension)" |
| 11. Part I "A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren’s Disease" |
| 12. Part II "A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients with Primary Sjögren’s Disease" |
| 13. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)" |
| 14. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants with Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)" |
| 15. Part I "A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma" |
| 16. Part II "A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma" |
| 17. Part I "An open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets" |
| 18. Part II "An open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets" |
| 19. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease (AD) (ADEPT-4)" |
| 20. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease (AD) (ADEPT-4)" |
| 21. Part I "A randomized, double blind, placebo controlled, parallel group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps" |
| 22. Part II "A randomized, double blind, placebo controlled, parallel group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps" |
| 23. Part I "An open-label, single-dose, parallel-group study to evaluate the plasma pharmacokinetics of leniolisib in subjects with impaired hepatic function and in subjects with normal hepatic function" |
| 24. Part II "An open-label, single-dose, parallel-group study to evaluate the plasma pharmacokinetics of leniolisib in subjects with impaired hepatic function and in subjects with normal hepatic function" |
| 25. Part I "A randomized, double blind, placebo controlled, parallel group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps" |
| 26. Part II "A randomized, double blind, placebo controlled, parallel group, 52-week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequately-controlled chronic rhinosinusitis with nasal polyps" |
| 27. Part I "An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4-6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor (HR)-Positive, HER2-Negative Advanced-Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced-Metastatic Disease (FOURLIGHT-3)" |
| 28. Part II "An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4-6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor (HR)-Positive, HER2-Negative Advanced-Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced-Metastatic Disease (FOURLIGHT-3)" |
| 29. Part I "KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling _x000D_Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)" |
| 30. Part II "KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling_x000D_ Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)" |
| 31. Part I "A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept_x000D_ Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors" |
| 32. Part II "A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept_x000D_ Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors" |
| 33. Part I "Multinational, multicentre, double-blind study to evaluate the efficacy and safety of bovine chondroitin sulfate 800 mg tablets versus marine chondroitin sulfate 800 mg tablets in the treatment of pain and functional impairment due to knee osteoarthritis" |
| 34. Part II "Multinational, multicentre, double-blind study to evaluate the efficacy and safety of bovine chondroitin sulfate 800 mg tablets versus marine chondroitin sulfate 800 mg tablets in the treatment of pain and functional impairment due to knee osteoarthritis" |
| 35. Part I "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled_x000D_ Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naďve Participants with Active Psoriatic Arthritis" |
| 36. Part II "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled_x000D_ Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-naďve Participants with Active Psoriatic Arthritis" |
| 37. Part I "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN´S DISEASE" |
| 38. Part II "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN´S DISEASE" |
| 39. Part I "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN´S DISEASE" |
| 40. Part II "A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, TREAT-THROUGH STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION AND MAINTENANCE THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN´S DISEASE" |
| 41. Part I "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis" |
| 42. Part II "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced Participants with Active Psoriatic Arthritis" |
| 43. Part I "A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure" |
| 44. Part II "A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death in Participants with Increased Risk of Developing Heart Failure" |
| 45. Part I "A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure" |
| 46. Part II "A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure" |
| 47. Part I "Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)" |
| 48. Part II "Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)" |
| 49. Part I "A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants with Systemic Sclerosis" |
| 50. Part II "A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants with Systemic Sclerosis" |
| 51. Part I "Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety" |
| 52. Part II "Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety" |
| 53. Part I "A Phase 3, Open-Label, Multicenter, Randomized Study of a Combination of CBP501, Cisplatin and Nivolumab or Physicianfs Choice of Therapy for ,3rd Line Treatment of Patients with Advanced Pancreatic Adenocarcinoma [FUJI-PanC01]" |
| 54. Part II "A Phase 3, Open-Label, Multicenter, Randomized Study of a Combination of CBP501, Cisplatin and Nivolumab or Physicianfs Choice of Therapy for ,3rd Line Treatment of Patients with Advanced Pancreatic Adenocarcinoma [FUJI-PanC01]" |
| 55. Part I "A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)" |
| 56. Part II "A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)" |
| 57. Part I "A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)" |
| 58. Part II "A Global Multicenter, Double-Blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination with Azacitidine (AZA) in Patients with Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4)" |
| 59. Part I "LuCa-MERIT-1: First-in-human, open label, Phase 1 dose confirmation trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer" |
| 60. Part II "LuCa-MERIT-1: First-in-human, open label, Phase 1 dose confirmation trial evaluating the safety, tolerability, and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer" |
| 61. Part I "A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants with Sjögren’s Syndrome (SS)" |
| 62. Part II "A Multicenter, Long-term, Randomized, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants with Sjögren’s Syndrome (SS)" |
| 63. Part I "A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT" |
| 64. Part II "A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT" |
| 65. Part I "Impact of Biweekly and Triweekly Dosing Regimens on Progression-Free Survival in First-Line FOLFIRI-Based Treatment of Metastatic Colorectal Cancer: A Non-Inferiority Study (FIR-DIR)" |
| 66. Part II "Impact of Biweekly and Triweekly Dosing Regimens on Progression-Free Survival in First-Line FOLFIRI-Based Treatment of Metastatic Colorectal Cancer: A Non-Inferiority Study (FIR-DIR)" |
| 67. Part I "An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001 (ONWARD3)" |
| 68. Part II "An Extension Study in Patients with Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001 (ONWARD3)" |
| 69. Part I "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn´s Disease" |
| 70. Part II "A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects with Moderately to Severely Active Crohn´s Disease" |
| 71. Part I "A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration" |
| 72. Part I "A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroids (UMBRIEL)" |
| 73. Part II "A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroids (UMBRIEL)" |
| 74. Part I "A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects with Moderate to Severe Genital Psoriasis" |
| 75. Part II "A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects with Moderate to Severe Genital Psoriasis" |
| 76. Part I "A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis" |
| 77. Part II "A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled and Ustekinumab Active Comparator-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis" |
| 78. Part I "A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)" |
| 79. Part II "A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naďve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)" |
| 80. Part I "A Phase 1a-1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia" |
| 81. Part II "A Phase 1a-1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia" |
| 82. Part I "A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa," |
| 83. Part II "A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa," |
| 84. Part I „Assessing the efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients (EXOTIC): A double-blind, randomized, placebo-controlled, phase 4 study” |
| 85. Part II „Assessing the efficacy of Elixirium thymi compositum in the treatment of acute bronchitis in pediatric patients (EXOTIC): A double-blind, randomized, placebo-controlled, phase 4 study” |
| 86. Part I "A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants with Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn’s Disease" |
| 87. Part II "A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants with Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn’s Disease" |
| 88. Part I "A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (JOURNEY)" |
| 89. Part II "A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (JOURNEY)" |
| 90. Part I "A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)" |
| 91. Part II "A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)" |
| 92. Part I "A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjögren´s Disease (SjD)" |
| 93. Part II "A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjögren´s Disease (SjD)" |
| 94. Part I "A Phase 3, Multi-center, Double-blind, 2-part Study in Participants with KRAS G12C-Mutant, Non-Small Cell Lung Cancer Comparing the Efficacy and Safety of Olomorasib in Combination with Standard of Care to Placebo in Combination with Standard of Care as Adjuvant Treatment after Platinum-based Chemotherapy" |
| 95. Part II "A Phase 3, Multi-center, Double-blind, 2-part Study in Participants with KRAS G12C-Mutant, Non-Small Cell Lung Cancer Comparing the Efficacy and Safety of Olomorasib in Combination with Standard of Care to Placebo in Combination with Standard of Care as Adjuvant Treatment after Platinum-based Chemotherapy" |
| 96. Part I "A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)," |
| 97. Part II "A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)," |
| 98. Part I "A phase Ib open-label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)" |
| 99. Part II "A phase Ib open-label randomised clinical trial to evaluate safety and efficacy of BI 770371 in combination with pembrolizumab with or without cetuximab compared with pembrolizumab monotherapy for the first-line treatment of patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)" |
| 100. Part I "A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, versus Standard of Care Therapy in Participants with Relapsed-Refractory Aggressive B-cell non-Hodgkin Lymphoma (OLYMPIA-4)" |
| 101. Part II "A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, versus Standard of Care Therapy in Participants with Relapsed-Refractory Aggressive B-cell non-Hodgkin Lymphoma (OLYMPIA-4)" |
| 102. Part I "A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)" |
| 103. Part II "A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)" |
| 104. Part I "An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care" |
| 105. Part II "An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care" |
| 106. Part I "A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age" |
| 107. Part II "A Phase 3, Multicenter, 12-Week, Double Blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age" |
| 108. Part I "A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia" |
| 109. Part II "A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia" |
| 110. Part I "A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD" |
| 111. Part II "A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD" |
| 112. Part I "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of T7-010 in Healthy Participants" |
| 113. Part II "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics of T7-010 in Healthy Participants" |
| 114. Part I "A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs, Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)" |
| 115. Part II "A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs, Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)" |
| 116. Part I "A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)" |
| 117. Part II "A Multi-phase, Dose-Escalation followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)" |
| 118. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis" |
| 119. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis" |
| 120. Part I "A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis" |
| 121. Part II "A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis" |
| 122. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)" |
| 123. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)" |
| 124. Part I "A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Active, Difficult-to-treat, ACPA-Positive Rheumatoid Arthritis" |
| 125. Part II "A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Active, Difficult-to-treat, ACPA-Positive Rheumatoid Arthritis" |
| 126. Part I "A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)" |
| 127. Part II "A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)" |
| 128. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy" |
| 129. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations who are Ineligible for Intensive Chemotherapy" |
| 130. Part I "A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves´ Disease" |
| 131. Part II "A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves´ Disease" |
| 132. Part I "A Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-tosevere ulcerative colitis" |
| 133. Part II "A Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-tosevere ulcerative colitis" |
| 134. Part I "An Open-Label, Randomized, Controlled Phase 3 Study of Sigvotatug Vedotin in Combination with Pembrolizumab Compared with Pembrolizumab Monotherapy as First-Line Treatment in Participants with PD-L1 High (,50% of Tumor Cells Expressing PD-L1), Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (Be6A Lung-02)" |
| 135. Part II "An Open-Label, Randomized, Controlled Phase 3 Study of Sigvotatug Vedotin in Combination with Pembrolizumab Compared with Pembrolizumab Monotherapy as First-Line Treatment in Participants with PD-L1 High (,50% of Tumor Cells Expressing PD-L1), Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (Be6A Lung-02)" |
| 136. Part I "Reversal of pipecuronium-induced neuromuscular blockade with Sugammadex during sevoflurane anesthesia: a drug safety randomised controlled trial" |
| 137. Part II "Reversal of pipecuronium-induced neuromuscular blockade with Sugammadex during sevoflurane anesthesia: a drug safety randomised controlled trial" |
| 138. Part I "Reversal of Pipecuronium-induced neuromuscular blockade using Sugammadex during propofol anaesthesia: a drug safety randomised controlled trial" |
| 139. Part II "Reversal of Pipecuronium-induced neuromuscular blockade using Sugammadex during propofol anaesthesia: a drug safety randomised controlled trial" |
| 140. Part I "A randomized, double-blind, placebo controlled, dose-ranging study evaluating the efficacy and safety of EVO756 in adults with moderate to severe chronic spontaneous urticaria" |
| 141. Part II "A randomized, double-blind, placebo controlled, dose-ranging study evaluating the efficacy and safety of EVO756 in adults with moderate to severe chronic spontaneous urticaria" |
| 142. Part I "A PHASE 3 OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PLOZASIRAN IN ADULTS WITH HYPERTRIGLYCERIDEMIA (SHASTA-10 STUDY)" |
| 143. Part II "A PHASE 3 OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PLOZASIRAN IN ADULTS WITH HYPERTRIGLYCERIDEMIA (SHASTA-10 STUDY)" |
| 144. Part I "A Phase 3 Randomized, Open-label, Multicenter Study to Compare the_x000D_ Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033-GOG-3119-ENGOT-en29)" |
| 145. Part II "A Phase 3 Randomized, Open-label, Multicenter Study to Compare the_x000D_ Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033-GOG-3119-ENGOT-en29)" |
| 146. Part I "A phase III, randomised, open-label, blinded endpoint, comparative trial of ferric derisomaltose versus no intravenous iron in iron-deficient subjects with symptomatic chronic heart failure" |
| 147. Part II "A phase III, randomised, open-label, blinded endpoint, comparative trial of ferric derisomaltose versus no intravenous iron in iron-deficient subjects with symptomatic chronic heart failure" |
| 148. Part I "Comparing the efficacy and safety of extended (3 h) and intermittent infusion (0,5 h) of beta-lactams (cefepime, ceftazidime, ceftriaxone, meropenem, piperacillin-tazobactam) in critically ill paediatric patients (PEBBLE)," (randomised, controlled clinical trial)" |
| 149. Part II "Comparing the efficacy and safety of extended (3 h) and intermittent infusion (0,5 h) of beta-lactams (cefepime, ceftazidime, ceftriaxone, meropenem, piperacillin-tazobactam) in critically ill paediatric patients (PEBBLE)," (randomised, controlled clinical trial)" |
| 150. Part I "First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication" |
| 151. Part II "First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication" |
| 152. Part I "A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis" |
| 153. Part II "A Phase 2a, Two-Part, Open-Label and Randomized Study to Evaluate the Safety and Efficacy of OD-07656 and of Subsequent Vedolizumab Therapy in Patients with Moderately to Severely Active Ulcerative Colitis" |
| 154. Part I "A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma" |
| 155. Part II "A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma" |
| 156. Part I "A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists, (FINALITY-HF)" |
| 157. Part II "A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists, (FINALITY-HF)" |
| 158. Part I "A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty" |
| 159. Part II "A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty" |
| 160. Part I "A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and safety of Debio 4126, a 12-week octreotide formulation, in patients with acromegaly previously treated with somatostatin analogs" |
| 161. Part II "A Phase 3 randomized 3-arm trial (double-blind Debio 4126, placebo control, and open-label Debio 4126), to assess the efficacy and safety of Debio 4126, a 12-week octreotide formulation, in patients with acromegaly previously treated with somatostatin analogs" |
| 162. Part I "A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Olverembatinib Combined with Chemotherapy Versus Investigator’s Choice of TKI Combined with Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) (POLARIS-1)" |
| 163. Part II "A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Olverembatinib Combined with Chemotherapy Versus Investigator’s Choice of TKI Combined with Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) (POLARIS-1)" |
| 164. Part I "A Phase 2 Multicenter, Randomized, Platform Study of Targeted_x000D_ Therapies for the Treatment of Adult Subjects with Active_x000D_ Psoriatic Arthritis" |
| 165. Part II "A Phase 2 Multicenter, Randomized, Platform Study of Targeted_x000D_ Therapies for the Treatment of Adult Subjects with Active Psoriatic Arthritis" |
| 166. Part I "A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINYOvarian01- ENGOT-ov89- GEICO144-O - GOG-3112)" |
| 167. Part II "A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan with Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINYOvarian01- ENGOT-ov89- GEICO144-O - GOG-3112)" |
| 168. Part I "A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection" |
| 169. Part II "A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection" |
| 170. Part I "VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant_x000D_ and CDK4-6 Inhibitors With or Without Gedatolisib as First-Line Treatme in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer" |
| 171. Part II "VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4-6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer" |
| 172. Part I "A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with an open-label period and long-term extension to assess the efficacy and safety of rilzabrutinib in participants with warm autoimmune hemolytic anemia (wAIHA)" |
| 173. Part II "A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with an open-label period and long-term extension to assess the efficacy and safety of rilzabrutinib in participants with warm autoimmune hemolytic anemia (wAIHA)" |
| 174. Part I "A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study of Lepodisiran in Participants with Normal Hepatic Function and Participants with Mild, Moderate, or Severe Hepatic Impairment" |
| 175. Part II "A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study of Lepodisiran in Participants with Normal Hepatic Function and Participants with Mild, Moderate, or Severe Hepatic Impairment" |
| 176. Part I "A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Naive to Targeted Therapies," |
| 177. Part II "A Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who are Naive to Targeted Therapies," |
| 178. Part I "A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)" |
| 179. Part II "A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)" |
| 180. Part I "Corticotrophin Releasing Factor 2 Agonist For the Treatment of Worsening Heart Failure (WHF) – The CRAFT-WHF Study" |
| 181. Part II "Corticotrophin Releasing Factor 2 Agonist For the Treatment of Worsening Heart Failure (WHF) – The CRAFT-WHF Study" |
| 182. Part I "VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4-6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer" |
| 183. Part I "A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)" |
| 184. Part II "A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)" |
| 185. Part I "A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy" |
| 186. Part II "A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy" |
| 187. Part I "A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET with high disease burden (NETTER-3)" |
| 188. Part II "A phase III multi-center, randomized, open-label study to evaluate the efficacy and safety of [177Lu]Lu-DOTA-TATE in patients newly diagnosed with Grade 1 and Grade 2 (Ki-67 <10%) advanced GEP-NET with high disease burden (NETTER-3)" |
| 189. Part I "A phase Ib, open-label, ascending dose study to assess safety, tolerability and pharmacokinetics of PIT565 in participants with rheumatoid arthritis (RA)" |
| 190. Part II "A phase Ib, open-label, ascending dose study to assess safety, tolerability and pharmacokinetics of PIT565 in participants with rheumatoid arthritis (RA)" |
| 191. Part I "A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2-3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0,5mg) in Participants with Diabetic Macular Edema" |
| 192. Part II "A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2-3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0,5mg) in Participants with Diabetic Macular Edema" |
| 193. Part I "AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with_x000D_ Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis" |
| 194. Part II "AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with_x000D_ Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis" |
| 195. Part I "EASi-HF Reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) <40%" |
| 196. Part II "EASi-HF Reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) <40%" |
| 197. Part I "A 16-Week, Multicenter, Interventional, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate Efficacy and Safety of Abrocitinib in Children 6 to Less Than 12 Years of Age with Moderate-to-Severe Atopic Dermatitis" |
| 198. Part II "A 16-Week, Multicenter, Interventional, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate Efficacy and Safety of Abrocitinib in Children 6 to Less Than 12 Years of Age with Moderate-to-Severe Atopic Dermatitis" |
| 199. Part I "A phase 2, multicentre, open-label, single arm study to evaluate the effectiveness and safety of rezafungin (as acetate) in the treatment of chronic pulmonary aspergillosis (CPA) in patients with limited treatment options" |
| 200. Part II "A phase 2, multicentre, open-label, single arm study to evaluate the effectiveness and safety of rezafungin (as acetate) in the treatment of chronic pulmonary aspergillosis (CPA) in patients with limited treatment options" |
| 201. Part I "DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First- Line Therapy of HER2-Expressing (IHC 3+-2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer" |
| 202. Part II "DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First- Line Therapy of HER2-Expressing (IHC 3+-2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer" |
| 203. Part I "REVEAL: Phase 3 Study of the Efficacy and Safety of ION582 in Children and Adults with Angelman Syndrome" |
| 204. Part II "REVEAL: Phase 3 Study of the Efficacy and Safety of ION582 in Children and Adults with Angelman Syndrome" |
| 205. Part I "A Phase 2b multi-national, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study followed by a long-term extension to evaluate the efficacy and safety of SAR442970 in adult participants with moderate to severe ulcerative colitis" |
| 206. Part II "A Phase 2b multi-national, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study followed by a long-term extension to evaluate the efficacy and safety of SAR442970 in adult participants with moderate to severe ulcerative colitis" |
| 207. Part I "A PHASE I-II, OPEN-LABEL, SINGLE-ARM, TWO-PART TRIAL TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF GLOFITAMAB IN MONOTHERAPY AND IN COMBINATION WITH CHEMOIMMUNOTHERAPY IN PEDIATRIC AND YOUNG ADULT PARTICIPANTS WITH RELAPSED-REFRACTORY MATURE B-CELL NON-HODGKIN LYMPHOMA" |
| 208. Part II "A PHASE I-II, OPEN-LABEL, SINGLE-ARM, TWO-PART TRIAL TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI-TUMOR ACTIVITY OF GLOFITAMAB IN MONOTHERAPY AND IN COMBINATION WITH CHEMOIMMUNOTHERAPY IN PEDIATRIC AND YOUNG ADULT PARTICIPANTS WITH RELAPSED-REFRACTORY MATURE B-CELL NON-HODGKIN LYMPHOMA" |
| 209. Part I "A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)" |
| 210. Part II "A Phase 2 Multicenter, Randomized, Double-masked, Sham-controlled, Reference-arm Study to Evaluate Efficacy and Safety of ONL1204 in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD)" |
| 211. Part I "A Phase III, randomised, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2,5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY® Study)," |
| 212. Part II "A Phase III, randomised, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2,5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY® Study)," |
| 213. Part I KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) |
| 214. Part II KEYMAKER-U01 Master Study: A Phase 1-2, Umbrella Study with Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants with Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) |
| 215. "A single-centre, partially blind, randomised, parallel-group, two-arms, superiority study to compare the efficacy and safety of extended (3 h) and intermittent infusion (0,5 h) of β-lactams (cefepime, ceftriaxone, meropenem, piperacillin-tazobactam) in critically ill paediatric patients (PEBBLE)"_x000D_ |
| 216. "A single-centre, partially blind, randomised, parallel-group, two-arms, superiority study to compare the efficacy and safety of extended (3 h) and intermittent infusion (0,5 h) of β-lactams (cefepime, ceftriaxone, meropenem, piperacillin-tazobactam) in critically ill paediatric patients (PEBBLE)"_x000D_ |
| 217. Part I KEYMAKER-U01 Master Study: A Phase 1-2, Umbrella Study with Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants with Non-small Cell Lung Cancer (NSCLC)_x000D_ KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous_x000D_ Non-small Cell Lung Cancer (NSCLC) |
| 218. Part II KEYMAKER-U01 Master Study: A Phase 1-2, Umbrella Study with Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants with Non-small Cell Lung Cancer (NSCLC)_x000D_ KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous_x000D_ Non-small Cell Lung Cancer (NSCLC) |
| 219. INTENSE: Changes in plaque characteristics after short-term intensified statin therapy as assessed by cardiac CT |
| 220. INTENSE: Changes in plaque characteristics after short-term intensified statin therapy as assessed by cardiac CT |
| 221. A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis |
| 222. A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis |
| 223. Impact of Biweekly and Triweekly Dosing Regimens on Progression-Free Survival in First-Line FOLFIRI Treatment of Metastatic Colorectal Cancer: A Non-Inferiority Study (FIR-DIR) |
| 224. Impact of Biweekly and Triweekly Dosing Regimens on Progression-Free Survival in First-Line FOLFIRI Treatment of Metastatic Colorectal Cancer: A Non-Inferiority Study (FIR-DIR) |
| 225. Part I "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)" |
| 226. Part II "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)" |
| 227. Part I "A Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults with Major Depressive Disorder (MDD), with or without Anxious Distress" |
| 228. Part II "A Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults with Major Depressive Disorder (MDD), with or without Anxious Distress" |
| 229. Part I "A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)" |
| 230. Part II "A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)" |
| 231. Part I "A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Elevated Low-Density Lipoprotein Cholesterol and Clinical Atherosclerotic Cardiovascular Disease or at Risk for a First Atherosclerotic Cardiovascular Disease Event" |
| 232. Part II "A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Elevated Low-Density Lipoprotein Cholesterol and Clinical Atherosclerotic Cardiovascular Disease or at Risk for a First Atherosclerotic Cardiovascular Disease Event" |
| 233. Part I "A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants with Prior Myocardial Infarction who have Elevated Coronary Inflammation Based on Fat Attenuation Index (FAI) Score Assessed by Coronary Computed Tomography Angiography (CCTA)" |
| 234. Part II "A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants with Prior Myocardial Infarction who have Elevated Coronary Inflammation Based on Fat Attenuation Index (FAI) Score Assessed by Coronary Computed Tomography Angiography (CCTA)" |
| 235. Part I "A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects Of Subcutaneous Ublituximab Versus Intravenous Ublituximab In Patients With Multiple Sclerosis" |
| 236. Part II "A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects Of Subcutaneous Ublituximab Versus Intravenous Ublituximab In Patients With Multiple Sclerosis" |
| 237. Part I "A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3_x000D_ Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with_x000D_ Moderate to Severe Sjögren´s Disease (SjD)" |
| 238. Part II "A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjögren´s Disease (SjD)" |
| 239. Part I "RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures" |
| 240. Part I "A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib" |
| 241. Part II "A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib" |
| 242. Part I "A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With_x000D_ Nonsegmental Vitiligo" |
| 243. Part II "A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of_x000D_ Ruxolitinib Cream in Children (6 to < 12 Years Old) With_x000D_ Nonsegmental Vitiligo" |
| 244. Part I "A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3–Directed Bispecific Antibody Therapy" |
| 245. Part II "A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3–Directed Bispecific Antibody Therapy" |
| 246. Part I "A Phase III, 52-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, with a primary efficacy endpoint at 12 weeks, to determine the efficacy, safety, and tolerability of a fixed dose of 15 mg bid and 30 mg bid of evenamide as add-on in patients with documented treatment-resistant schizophrenia, which is not adequately controlled by a stable therapeutic dose of the patient’s current antipsychotic medication(s)" |
| 247. Part II "A Phase III, 52-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, with a primary efficacy endpoint at 12 weeks, to determine the efficacy, safety, and tolerability of a fixed dose of 15 mg bid and 30 mg bid of evenamide as add-on in patients with documented treatment-resistant schizophrenia, which is not adequately controlled by a stable therapeutic dose of the patient’s current antipsychotic medication(s)" |
| 248. Part I "A randomized, phase 3, double-blind, double-dummy, active comparatorcontrolled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D," |
| 249. Part II "A randomized, phase 3, double-blind, double-dummy, active comparatorcontrolled multicenter study to evaluate the efficacy and safety of 2 doses of linaprazan glurate compared to lansoprazole in 4 or 8 weeks healing in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) of Los Angeles (LA) grades A to D," |
| 250. Part I "A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial" |
| 251. Part II "A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial" |
| 252. Part I "A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison with Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects with Resected Non-Small Cell Lung Cancer," |
| 253. Part II "A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison with Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects with Resected Non-Small Cell Lung Cancer," |
| 254. Part I "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema – ALPHA-ORBIT" |
| 255. Part II "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants with Hereditary Angioedema – ALPHA-ORBIT" |
| 256. Part I "A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Heterozygous Familial Hypercholesterolaemia" |
| 257. Part II "A Phase III, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Effect of AZD0780 on Low-Density Lipoprotein Cholesterol in Patients With Heterozygous Familial Hypercholesterolaemia" |
| 258. Part I "A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Crohn’s Disease and Obesity or Overweight" |
| 259. Part II "A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Crohn’s Disease and Obesity or Overweight" |
| 260. Part I "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus" |
| 261. Part II "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus" |
| 262. Part I "A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania with Mixed Features in Bipolar-I Disorder (BALSAM-3)," |
| 263. Part II "A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania with Mixed Features in Bipolar-I Disorder (BALSAM-3)," |
| 264. Part I "A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight" |
| 265. Part II "A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight" |
| 266. Part I "A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ASTHMA" |
| 267. Part II "A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ASTHMA" |
| 268. Part I "A Phase I, Open-label, Non-randomized, Parallel Group, Single dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIA 28-6156 and its Metabolites in Participants with Different Degrees of Renal Impairment and Normal Renal Function" |
| 269. Part II "A Phase I, Open-label, Non-randomized, Parallel Group, Single dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIA 28-6156 and its Metabolites in Participants with Different Degrees of Renal Impairment and Normal Renal Function" |
| 270. Part I "A phase Ib, open-label, ascending dose study with step-up doses to assess safety, tolerability, and pharmacokinetics of PIT565 in participants with systemic lupus erythematosus (SLE)" |
| 271. Part II "A phase Ib, open-label, ascending dose study with step-up doses to assess safety, tolerability, and pharmacokinetics of PIT565 in participants with systemic lupus erythematosus (SLE)" |
| 272. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease" |
| 273. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease" |
| 274. Part I "A RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND OPEN-LABEL ACTIVE COMPARATOR- CONTROLLED, PARALLEL-GROUP, MULTI-CENTER PHASE II STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ONCE-DAILY RO7795081 ADMINISTERED FOR 30 WEEKS TO PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS" |
| 275. Part II "A RANDOMIZED, DOUBLE-BLIND, PLACEBO- AND OPEN-LABEL ACTIVE COMPARATOR- CONTROLLED, PARALLEL-GROUP, MULTI-CENTER PHASE II STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ONCE-DAILY RO7795081 ADMINISTERED FOR 30 WEEKS TO PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS" |
| 276. Part I "A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa" |
| 277. Part II "A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa" |
| 278. Part I "A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event," |
| 279. Part II "A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients with Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event," |
| 280. Part I "A phase 2, multi-center study consisting of a randomized, placebocontrolled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa" |
| 281. Part II "A phase 2, multi-center study consisting of a randomized, placebocontrolled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa" |
| 282. Part I "A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)" |
| 283. Part II "A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)" |
| 284. Part I "A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)" |
| 285. Part II "A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)" |
| 286. Part I "A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy" |
| 287. Part II "A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy" |
| 288. Part I "A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)" |
| 289. Part II "A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)" |
| 290. Part I "A multicenter, open-label, randomized Phase 3 study evaluating THIO sequenced with cemiplimab (LIBTAYO®) vs, Investigator choice of single-agent chemotherapy as third-line treatment in subjects with advanced - metastatic non-small cell lung cancer" |
| 291. Part II "A multicenter, open-label, randomized Phase 3 study evaluating THIO sequenced with cemiplimab (LIBTAYO®) vs, Investigator choice of single-agent chemotherapy as third-line treatment in subjects with advanced - metastatic non-small cell lung cancer" |
| 292. Part I "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)" |
| 293. Part II "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)" |
| 294. Part I "A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis" |
| 295. Part II "A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis" |
| 296. Part I "A Multicenter, Randomized, Double-Blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study_x000D_ Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP" |
| 297. Part II "A Multicenter, Randomized, Double-Blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study_x000D_ Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP" |
| 298. Part I "A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis" |
| 299. Part II "A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis" |
| 300. Part I "A Double-blind, Randomized, Placebo -controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)" |
| 301. Part II "A Double-blind, Randomized, Placebo -controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)" |
| 302. Part I "A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)" |
| 303. Part II "A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)" |
| 304. Part I "Changes in plaque characteristics after short-term statin therapy assessed with coronary CT" |
| 305. Part II "Changes in plaque characteristics after short-term statin therapy assessed with coronary CT" |
| 306. Part I "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab-LY3650150 in Participants with Chronic Rhinosinusitis with Nasal Polyps on Background Intranasal Corticosteroids" |
| 307. Part II "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab-LY3650150 in Participants with Chronic Rhinosinusitis with Nasal Polyps on Background Intranasal Corticosteroids" |
| 308. Part I "A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer DeLLphi-310" |
| 309. Part II "A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer DeLLphi-310" |
| 310. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF) Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)" |
| 311. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF) Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)" |
| 312. Part I "A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis" |
| 313. Part II "A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis" |
| 314. Part I "A randomized, double-blind, placebo-controlled, parallelgroup study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide," |
| 315. Part II "A randomized, double-blind, placebo-controlled, parallelgroup study to assess the efficacy, safety, and tolerability of SAR444336 in participants with microscopic colitis in clinical remission with budesonide," |
| 316. Part I "A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease" |
| 317. Part II "A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease" |
| 318. Part I "Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)" |
| 319. Part II "Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)" |
| 320. Part I "Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation" |
| 321. Part II "Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation" |
| 322. Part I "A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease" |
| 323. Part II "A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease" |
| 324. Part I "A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly" |
| 325. Part II "A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination with Somatostatin Analogs in Adult Participants with Acromegaly" |
| 326. Part I "An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptorpositive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)" |
| 327. Part II "An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptorpositive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)" |
| 328. Part I "A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis" |
| 329. Part II "A Phase 2b, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis" |
| 330. Part I "LIGHTBEAM-U01 Substudy 01C: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors" |
| 331. Part II "LIGHTBEAM-U01 Substudy 01C: A Phase 1-2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors" |
| 332. Part I "A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed-Refractory (R-R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)" |
| 333. Part II "A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults with Relapsed-Refractory (R-R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton’s Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)" |
| 334. Part I "Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2-3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke with Late Presentations" |
| 335. Part II "Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2-3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke with Late Presentations" |
| 336. Part I "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)" |
| 337. Part II "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)" |
| 338. Part I "A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis," |
| 339. Part II "A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis," |
| 340. Part I "A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment" |
| 341. Part II "A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment" |
| 342. Part I "A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXIAPEX)" |
| 343. Part II "A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXIAPEX)" |
| 344. Part I "A randomised, double-masked, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of oral BI 1815368 in participants with centre-involved diabetic macular edema for 48 weeks of treatment (THULITE)" |
| 345. Part II "A randomised, double-masked, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of oral BI 1815368 in participants with centre-involved diabetic macular edema for 48 weeks of treatment (THULITE)" |
| 346. Part I "A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)" |
| 347. Part II "A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)" |
| 348. Part I "A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)" |
| 349. Part II "A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)" |
| 350. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)" |
| 351. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)" |
| 352. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - MOVE-Lp(a)" |
| 353. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Muvalaplin on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a) who have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - MOVE-Lp(a)" |
| 354. Part I "A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled_x000D_ Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in_x000D_ Participants with Colorectal Cancer who have Cancer Cachexia" |
| 355. Part II "A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled_x000D_ Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in_x000D_ Participants with Colorectal Cancer who have Cancer Cachexia" |
| 356. Part I "STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema" |
| 357. Part II "STOP-HAE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema" |
| 358. Part I "A Phase 3, Randomized, Open-Label Study of BET Inhibitor INCB057643 Versus Best Available_x000D_ Therapy in Participants With Myelofibrosis Previously Treated With a JAK Inhibitor (BETRMF2)" |
| 359. Part I "A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-_x000D_Blind Study to Assess the Efficacy and Safety of IMVT-1402 in_x000D_ Patients With Mild to Severe Generalized Myasthenia Gravis" |
| 360. Part II "A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-_x000D_Blind Study to Assess the Efficacy and Safety of IMVT-1402 in_x000D_ Patients With Mild to Severe Generalized Myasthenia Gravis" |
| 361. Part I "A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022-ENGOT-ov84-GOG-3103)" |
| 362. Part II "A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022-ENGOT-ov84-GOG-3103)" |
| 363. Part I "A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON SMALL CELL LUNG CANCER" |
| 364. Part II "A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON SMALL CELL LUNG CANCER" |
| 365. Part I "A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)" |
| 366. Part II "A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)" |
| 367. Part I "AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY OF PF-07248144 PLUS FULVESTRANT COMPARED TO INVESTIGATOR’S CHOICE OF THERAPY IN ADULT PARTICIPANTS WITH_x000D_ HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE_x000D_ ADVANCED-METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK4-6 INHIBITOR-BASED THERAPY" |
| 368. Part II "AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY OF PF-07248144 PLUS FULVESTRANT COMPARED TO INVESTIGATOR’S CHOICE OF THERAPY IN ADULT PARTICIPANTS WITH_x000D_ HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE_x000D_ ADVANCED-METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK4-6 INHIBITOR-BASED THERAPY" |
| 369. Part I "A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants with Normal Hepatic Function and Participants with Mild, Moderate, or Severe Hepatic Impairment" |
| 370. Part II "A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants with Normal Hepatic Function and Participants with Mild, Moderate, or Severe Hepatic Impairment" |
| 371. Part I "Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes" |
| 372. Part II "Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes" |
| 373. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-2)" |
| 374. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-2)" |
| 375. Part I "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis" |
| 376. Part II "A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis" |
| 377. Part I "A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled_x000D_ Study of IMVT-1402 Treatment in Adult Participants with Chronic_x000D_ Inflammatory Demyelinating Polyneuropathy (CIDP)" |
| 378. Part II "A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled_x000D_ Study of IMVT-1402 Treatment in Adult Participants with Chronic_x000D_ Inflammatory Demyelinating Polyneuropathy (CIDP)" |
| 379. Part I "A Phase III, randomized, multi-site, open-label trial of BNT323-DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2-expressing recurrent endometrial cancer" |
| 380. Part II "A Phase III, randomized, multi-site, open-label trial of BNT323-DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2-expressing recurrent endometrial cancer" |
| 381. Part I "Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (The EXACT-2 Trial)" |
| 382. Part II "Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (The EXACT-2 Trial)" |
| 383. Part I "A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization" |
| 384. Part II "A Global, Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults with Schizophrenia Who Warrant Inpatient Hospitalization" |
| 385. Part I "A randomized Phase 2-3 Study of BMS-986504 in combination with pembrolizumab plus chemotherapy versus pembrolizumab plus chemotherapy in first line metastatic non-small cell lung cancer (mNSCLC) participants with homozygous MTAP deletion" |
| 386. Part II "A randomized Phase 2-3 Study of BMS-986504 in combination with pembrolizumab plus chemotherapy versus pembrolizumab plus chemotherapy in first line metastatic non-small cell lung cancer (mNSCLC) participants with homozygous MTAP deletion" |
| 387. Part I "A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV- RGX- 314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)" |
| 388. Part II "A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV- RGX- 314) in a eal-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)" |
| 389. Part I "A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress" |
| 390. Part II "A 6-Week, Multicenter, Open-Label, Monotherapy, Extension Study of SPT-300 in Adults with Major Depressive Disorder, With or Without Anxious Distress" |
| 391. Part I "Questionary to Fentanyl Nasal (F-PUFF) Spray Efficiancy and Safety" |
| 392. Part II "Questionary to Fentanyl Nasal (F-PUFF) Spray Efficiancy and Safety" |
| 393. Part I "Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting_x000D_ Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis," |
| 394. Part II "Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting_x000D_ Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis," |
| 395. Part I "A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization" |
| 396. Part II "A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization" |
| 397. Part I "A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+-HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4-6 Inhibitor" |
| 398. Part II "A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+-HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4-6 Inhibitor" |
| 399. Part I "A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)" |
| 400. Part II "A randomised, double-blind, placebo-controlled trial with an open-label extension to assess the pharmacokinetics, safety, and_x000D_ efficacy of empagliflozin tablets in paediatric patients with chronic kidney disease (EMPA-KIDNEY® Kids)" |
| 401. Part I "A multicenter, double-blind, randomized withdrawal study in patients with schizophrenia receiving either iloperidone long-acting injection (LAI) or placebo injection" |
| 402. Part II "A multicenter, double-blind, randomized withdrawal study in patients with schizophrenia receiving either iloperidone long-acting injection (LAI) or placebo injection" |
| 403. Part I "A Phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with Investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic-recurrent head and neck squamous cell carcinoma" |
| 404. Part II "A Phase 3 open-label, randomized, controlled study to evaluate the efficacy and safety of petosemtamab compared with Investigator’s choice monotherapy treatment in previously treated patients with incurable, metastatic-recurrent head and neck squamous cell carcinoma" |
| 405. Part I "Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)" |
| 406. Part II "Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)" |
| 407. Part I "Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells" |
| 408. Part II "Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells" |
| 409. Part I "A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior" |
| 410. Part II "A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior" |
| 411. Part I "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia" |
| 412. Part II "A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia" |
| 413. Part I "A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults with Schizophrenia" |
| 414. Part II "A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults with Schizophrenia" |
| 415. Part I "A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)" |
| 416. Part II "A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-Risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)" |
| 417. Part I "A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial" |
| 418. Part II "A Phase 2, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of 2 doses of vipoglanstat in patients with moderate to severe endometriosis-related pain – the NOVA trial" |
| 419. Part I "An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)" |
| 420. Part II "An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants with Severe Eosinophilic Asthma (EXHALE-5)" |
| 421. Part I "Phase 2-3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)" |
| 422. Part II "Phase 2-3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)" |
| 423. Part I "A randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation" |
| 424. Part II "A randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation" |
| 425. Part II "RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures" |
| 426. Part I "A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced-Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1-Anti-PD-L1 Therapy (Bluestar-Endometrial01)" |
| 427. Part II "A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced-Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1-Anti-PD-L1 Therapy (Bluestar-Endometrial01)" |
| 428. Part I "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study with Open-label Extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis" |
| 429. Part II "A Phase 3, randomized, double-blind, placebo-controlled, multicenter study with Open-label Extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis" |
| 430. Part I "A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy" |
| 431. Part II "A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy" |
| 432. Part I "The Role of Beta-Blockade During Cardiac CT in Patients with Atrial Fibrillation" |
| 433. Part II "The Role of Beta-Blockade During Cardiac CT in Patients with Atrial Fibrillation" |
| 434. Part I "A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed-Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)" |
| 435. Part II "A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed-Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)" |
| 436. Part I "A Phase 2b-3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s disease" |
| 437. Part II "A Phase 2b-3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants with Moderately to Severely Active Crohn’s disease" |
| 438. Part I "A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis" |
| 439. Part II "A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis" |
| 440. Part I "A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK- PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age with heart failure (HF) and left ventricular systolic dysfunction (LVSD)" |
| 441. Part II "A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK- PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age with heart failure (HF) and left ventricular systolic dysfunction (LVSD)" |
| 442. Part I "A phase 3, single arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)" |
| 443. Part II "A phase 3, single arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)" |
| 444. Part I "A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults with Moderate to Severe Atopic Dermatitis" |
| 445. Part II "A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults with Moderate to Severe Atopic Dermatitis" |
| 446. Part I "An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia" |
| 447. Part II "An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitor with Blinatumomab in Patients with Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-class Philadelphia Chromosome-Like B-cell Acute Lymphoblastic Leukemia" |
| 448. Part I "A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity" |
| 449. Part II "A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants with Primary Sjogren’s Disease with Moderate to Severe Systemic Disease Activity" |
| 450. Part I "A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer," |
| 451. Part II "A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer," |
| 452. Part I "A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis" |
| 453. Part II "A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Pharmacodynamics, Clinical Effects, and Safety between ABP 692 and Ocrevus® (Ocrelizumab) in Subjects with Relapsing-remitting Multiple Sclerosis" |
| 454. Part I "A Phase 2b-3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy" |
| 455. Part II "A Phase 2b-3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy" |
| 456. Part I "Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)" |
| 457. Part II "Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)" |
| 458. Part I "A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)" |
| 459. Part II "A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice-Weekly, Followed by a Long-Term, Open-Label Safety Evaluation in Patients with Short Bowel Syndrome–Intestinal Failure (SBS-IF)" |
| 460. Part I "A Phase Ib, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults_x000D_ with Pulmonary Arterial Hypertension (PAH)" |
| 461. Part II "A Phase Ib, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)" |
| 462. Part I "TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by openlabel, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer" |
| 463. Part II "TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by openlabel, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer" |
| 464. Part I "A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis" |
| 465. Part II "A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis" |
| 466. Part I "A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa" |
| 467. Part II "A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa" |
| 468. Part I "A Phase 1-2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis" |
| 469. Part II "A Phase 1-2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis" |
| 470. Part I "A Single center, open label Study to Evaluate Pharmacokinetics of NTRX-07 in fed and fasted participants" |
| 471. Part II "A Single center, open label Study to Evaluate Pharmacokinetics of NTRX-07 in fed and fasted participants" |
| 472. Part I "A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to_x000D_ sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)" |
| 473. Part II "A Phase 3, multicentre, randomised (1:1), parallel-group, active-controlled, central reader colonoscopist-blind study to evaluate the bowel cleansing efficacy, safety, tolerability, palatability, and acceptability of PLENVU® as compared to_x000D_ sodium picosulfate in paediatric participants from 1 to < 18 years of age in preparation for colonoscopy (CLARITY)" |
| 474. Part I "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants with Moderate-To-Severe Active Ulcerative Colitis" |
| 475. Part II "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants with Moderate-To-Severe Active Ulcerative Colitis" |
| 476. Part I "A Randomized, Open-Label, Multi-Center, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants with Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer with Disease Progression on or After Platinum-Based_x000D_ Chemotherapy and Anti-PD-1-PD-L1 Immunotherapy" |
| 477. Part I "A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as_x000D_ Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036-GOG-3123-ENGOT-cx22)" |
| 478. Part II "A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as_x000D_ Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036-GOG-3123-ENGOT-cx22)" |
| 479. Part I "A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naive Recurrent-Metastatic Head and Neck Squamous Cell Carcinoma (OrigAMI-5)" |
| 480. Part II "A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naive Recurrent-Metastatic Head and Neck Squamous Cell Carcinoma (OrigAMI-5)" |
| 481. Part I "An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX" |
| 482. Part II "An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX" |
| 483. Part I "A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)" |
| 484. Part II "A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)" |
| 485. Part I "A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)" |
| 486. Part II "A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)" |
| 487. Part I "A phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma" |
| 488. Part II "A phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma" |
| 489. Part I "A Phase 3b-4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)" |
| 490. Part II "A Phase 3b-4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)" |
| 491. Part I "A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis" |
| 492. Part II "A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis" |
| 493. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)" |
| 494. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-2)" |
| 495. Part I "ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease" |
| 496. Part II "ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease" |
| 497. Part I "A Phase 2b-3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy," |
| 498. Part II "A Phase 2b-3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy," |
| 499. Part I "A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors - CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)" |
| 500. Part II "A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors - CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)" |
| 501. Part I "A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer," |
| 502. Part II "A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer," |
| 503. Part I "A MULTI-CENTER, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE II STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF RO7268489, A MONOACYLGLYCEROL LIPASE INHIBITOR, AS ADD-ON THERAPY TO OCRELIZUMAB, IN PARTICIPANTS WITH PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS" |
| 504. Part II "A MULTI-CENTER, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE II STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF RO7268489, A MONOACYLGLYCEROL LIPASE INHIBITOR, AS ADD-ON THERAPY TO OCRELIZUMAB, IN PARTICIPANTS WITH PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS" |
| 505. Part I "A Phase 2-3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 506. Part II "A Phase 2-3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy" |
| 507. Part I "A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants with Metabolic Dysfunction-Associated Steatotic Liver Disease who are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes)" |
| 508. Part II "A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants with Metabolic Dysfunction-Associated Steatotic Liver Disease who are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes)" |
| 509. Part I "A Phase 3, Randomized, Multicenter, Open-Label Study of_x000D_ IDRX-42 (GSK6042981) versus Sunitinib in Participants with_x000D_ Metastatic and-or Unresectable Gastrointestinal Stromal_x000D_ Tumors (GIST) after Imatinib Therapy (StrateGIST 3)" |
| 510. Part II "A Phase 3, Randomized, Multicenter, Open-Label Study of_x000D_ IDRX-42 (GSK6042981) versus Sunitinib in Participants with_x000D_ Metastatic and-or Unresectable Gastrointestinal Stromal_x000D_ Tumors (GIST) after Imatinib Therapy (StrateGIST 3)" |
| 511. Part I "A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE" |
| 512. Part II "A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE" |
| 513. Part I "A Phase 1-2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and_x000D_ Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with_x000D_ Intermediate or High-risk Primary or Secondary Myelofibrosis" |
| 514. Part II "A Phase 1-2, Open-label, Dose-escalation, Safety, Pharmacokinetic, and_x000D_ Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients with_x000D_ Intermediate or High-risk Primary or Secondary Myelofibrosis" |
| 515. Part I "Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy," |
| 516. Part II "Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy," |
| 517. Part I "A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy" |
| 518. Part II "A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy" |
| 519. Part I "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis" |
| 520. Part II "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis" |
| 521. Part I "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living_x000D_ with Overweight or Obesity (MARITIME-OSA-1)" |
| 522. Part II "A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living_x000D_ with Overweight or Obesity (MARITIME-OSA-1)" |
| 523. Part I "TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)" |
| 524. Part II "TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)" |
| 525. Part I "A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant with Ribociclib Versus Letrozole with Ribociclib for the First-Line Treatment of ER+, HER2– Advanced Breast Cancer (OPERA-02)" |
| 526. Part II "A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant with Ribociclib Versus Letrozole with Ribociclib for the First-Line Treatment of ER+, HER2– Advanced Breast Cancer (OPERA-02)" |
| 527. Part I "A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis," |
| 528. Part II "A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis," |
| 529. Part I "A LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH ATOPIC DERMATITIS PREVIOUSLY TREATED WITH APG777" |
| 530. Part II "A LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH ATOPIC DERMATITIS PREVIOUSLY TREATED WITH APG777" |
| 531. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)" |
| 532. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)" |
| 533. Part I "An open-label, sequential, ascending, repeated dose-finding study of sarilumab, administered with Subcutaneous (SC) injection, in Children and Adolescents, aged 1 to 17 years, with Systemic Juvenile Idiopathic Arthritis (sJIA), followed by an extension phase" |
| 534. Part II "An open-label, sequential, ascending, repeated dose-finding study of sarilumab, administered with Subcutaneous (SC) injection, in Children and Adolescents, aged 1 to 17 years, with Systemic Juvenile Idiopathic Arthritis (sJIA), followed by an extension phase" |
| 535. Part I "A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion - RIDES" |
| 536. Part II "A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion - RIDES" |
| 537. Part I "A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin-Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, TripleNegative Breast Cancer or Hormone Receptor-low Positive-Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer" |
| 538. Part II "A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin-Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, TripleNegative Breast Cancer or Hormone Receptor-low Positive-Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer" |
| 539. Part I "A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)" |
| 540. Part II "A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)" |
| 541. Part I "Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta" |
| 542. Part II "Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment with Romosozumab in Children and Adolescents with Osteogenesis Imperfecta" |
| 543. Part I "A seamless Phase 2-3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients" |
| 544. Part II "A seamless Phase 2-3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients" |
| 545. Part I "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants with Established Atherosclerotic Cardiovascular Disease and-or Chronic Kidney Disease (ATTAIN-Outcomes)" |
| 546. Part II "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants with Established Atherosclerotic Cardiovascular Disease and-or Chronic Kidney Disease (ATTAIN-Outcomes)" |
| 547. Part I "A prospective, open-label, single-arm, multicenter study evaluating the efficacy of Xanomeline-Trospium (XT) on cognitive impairment after 24 and 52 weeks of treatment in adult participants with schizophrenia," |
| 548. Part II "A prospective, open-label, single-arm, multicenter study evaluating the efficacy of Xanomeline-Trospium (XT) on cognitive impairment after 24 and 52 weeks of treatment in adult participants with schizophrenia," |
| 549. Part I "A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis" |
| 550. Part II "A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis" |
| 551. Part I "A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa" |
| 552. Part II "A randomized, double-blind, placebo-controlled, Phase 2, dose-finding study to investigate the efficacy and safety of SAR445399 in participants with moderate to severe hidradenitis suppurativa" |
| 553. Part I "KEYMAKER-U01 Master Study: A Phase 1-2, Umbrella Study with Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants with Non-small Cell Lung Cancer (NSCLC)" |
| 554. Part II "KEYMAKER-U01 Master Study: A Phase 1-2, Umbrella Study with Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants with Non-small Cell Lung Cancer (NSCLC)" |
| 555. Part I "Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute_x000D_ Myeloid Leukemia" |
| 556. Part II "Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged Acute_x000D_ Myeloid Leukemia" |
| 557. Part I "An open-label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with asthma who participated in study DRI16762 or ACT18301" |
| 558. Part II "An open-label extension study to evaluate the long-term safety and efficacy of subcutaneous lunsekimig in adult participants with asthma who participated in study DRI16762 or ACT18301" |
| 559. Part I "A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to_x000D_ Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above" |
| 560. Part II "A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to_x000D_ Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above" |
| 561. Part I "A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)" |
| 562. Part II "A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)" |
| 563. Part I "A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)" |
| 564. Part II "A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with psoriatic arthritis (PsA)" |
| 565. Part I "A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)" |
| 566. Part II "A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD)" |
| 567. Part I "A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100-6-12,5 ěg HFA-152a versus CHF5993 pMDI 100-6-12,5 ěg HFA-134a in subjects with mild to moderate asthma (TRECONY)" |
| 568. Part II "A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100-6-12,5 ěg HFA-152a versus CHF5993 pMDI 100-6-12,5 ěg HFA-134a in subjects with mild to moderate asthma (TRECONY)" |
| 569. Part I "A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis" |
| 570. Part II "A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects with Idiopathic Pulmonary Fibrosis" |
| 571. Part I "Phase Ia-Ib Open Label, Multi-Centre Dose Escalation Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants with Advanced Malignancies" |
| 572. Part II "Phase Ia-Ib Open Label, Multi-Centre Dose Escalation Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of DSB2455 as Monotherapy in Participants with Advanced Malignancies" |
| 573. Part I "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease" |
| 574. Part II "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s disease" |
| 575. Part I "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease" |
| 576. Part II "A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn’s Disease" |
| 577. Part I "A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis" |
| 578. Part II "A multinational, multicenter extension study to investigate the long-term safety, tolerability and efficacy of balinatunfib in adults with Crohn’s disease or ulcerative colitis" |
| 579. Part I "TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i,v, tenecteplase vs standard of care in patients with acute ischemic stroke (including wake up stroke), last known well >4,5 h with imaging evidence of salvageable ischemic tissue" |
| 580. Part II "TENACITY – A Phase III, prospective, randomized, open-label, blinded endpoint assessment (PROBE) to assess efficacy and safety of i,v, tenecteplase vs standard of care in patients with acute ischemic stroke (including wake up stroke), last known well >4,5 h with imaging evidence of salvageable ischemic tissue" |
| 581. Part I "A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging_x000D_ study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of galvokimig in adult study participants with moderate to severe atopic dermatitis" |
| 582. Part II "A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging_x000D_ study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of galvokimig in_x000D_ adult study participants with moderate to severe atopic dermatitis" |