Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

PHASE2TerminatedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

January 31, 2022

Primary Completion Date

October 22, 2024

Study Completion Date

October 22, 2024

Conditions
Ulcerative Colitis
Interventions
DRUG

Efavaleukin alfa

Efavaleukin alfa will be administered by subcutaneous (SC) injection.

DRUG

Placebo

Placebo will be administered by SC injection.

Trial Locations (200)

1002

Pauls Stradins Clinical University Hospital, Riga

1024

MIND Klinika Kft, Budapest

1033

Clinexpert Kft, Budapest

1036

Obudai Egeszsegugyi Centrum Kft, Budapest

1079

Gastro Centrs, Riga

1090

Universitaetsklinikum Allgemeines Krankenhaus Wien, Vienna

1202

Second Multiprofile Hospital for Active Treatment - Sofia EAD, Sofia

1605

Clinica Independencia, Munro

1680

Diagnostic-Consultative Center Convex EOOD, Sofia

1784

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Mladost EOOD, Sofia

2000

Fundacion Estudios Clinicos, Rosario

2400

Bispebjerg Hospital, København NV

2650

Universitair Ziekenhuis Antwerpen, Edegem

Hvidovre Hospital, Hvidovre

2730

Herlev Hospital, Herlev

2800

Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabánya

3000

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3010

Inselspital Bern, Bern

3012

Intesto BE, Bern

4000

Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège

5020

Landeskrankenhaus Salzburg, Salzburg

5600

Bekes Varmegyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz, Békéscsaba

6020

Medizinische Universitaet Innsbruck, Innsbruck

6725

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged

7100

Clinfan Kft, Szekszárd

8091

Universitaetsspital Zuerich, Zurich

9000

Aalborg Universitetshospital, Aalborg

9007

Kantonsspital St Gallen, Sankt Gallen

10002

National Taiwan University Hospital, Taipei

10676

General Hospital Evangelismos, Athens

10825

Gastro-Studien GbR Studienzentrum, Berlin

11042

New York University Grossman School of Medicine and New York University Langone Hospitals, Lake Success

11217

Taipei Veterans General Hospital, Taipei

11527

Laiko General Hospital of Athens, Athens

12462

University Hospital Attikon, Haidari

16059

Uludag Universitesi Tip Fakultesi Hastanesi, Bursa

16132

Ospedale Policlinico San Martino IRCCS, Genoa

18840

Guthrie Robert Packer Hospital, Sayre

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20132

IRCCS Ospedale San Raffaele, Milan

20176

Emeritas Research Group, Lansdowne Town Center

20770

Mid-Atlantic GI Research, LLC, Greenbelt

23229

North Richmond Health Research, Richmond

23236

GI Select Health Research LLC, Richmond

23249

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

24502

Blue Ridge Medical Research, Lynchburg

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia

26426

Wonju Severance Christian Hospital, Wonju-si, Gangwon-do

26504

General University Hospital of Patras Panagia i Voithia, Pátrai

27310

Gaziantep Universitesi Tip Fakultesi Hastanesi, Gaziantep

28006

Hospital Universitario de La Princesa, Madrid

28028

Hospital General Universitario Gregorio Marañon, Madrid

28046

Hospital Universitario La Paz, Madrid

29204

Columbia Digestive Health Research LLC, Columbia

29425

Medical University of South Carolina, Charleston

30342

Atlanta Gastroenterology Associates, Atlanta

31901

Columbus Regional Research Institute, LLC, Columbus

32159

Lake Center for Clinical Research, Lady Lake

32771

Infigo Clinical Research, Sanford

32804

AdventHealth Medical Group Gastroenterology and Hepatology, Orlando

33032

Homestead Associates In Research Inc, Homestead

33136

University of Miami Hospital and Clinic, Miami

33343

Mersin Universitesi Tip Fakultesi Hastanesi, Mersin

33756

West Central Gastroenterology, Clearwater

33813

Auzmer Research, Lakeland

34093

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi, Istanbul

34295

Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi, Montpellier

34471

Ocala Gastrointestinal Research, LLC, Ocala

34741

Indian Health Service Health Research, Kissimmee

35100

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

35209

Birmingham Digestive Health Research, LLC, Homewood

35330

Dokuz Eylul Universitesi Tip Fakultesi Hastanesi, Izmir

36305

Digestive Health Specialists of the Southeast, Dothan

37024

Ospedale Sacro Cuore Don Calabria, Negrar VR

37076

Digestive Health Research, LLC, Hermitage

37421

Wake Research-ClinSearch, LLC, Chattanooga

39216

Southern Therapy and Advanced Research LLC - Jackson, Jackson

40447

China Medical University Hospital, Taichung

41001

Kocaeli Universitesi Tip Fakultesi Hastanesi, Kocaeli

42270

Centre Hospitalier Universitaire Nord de Saint Etienne - Hopital Nord, Saint-Priest-en-Jarez

42415

Yeungnam University Medical Center, Daegu

44650

Clinica de Investigacion en Reumatologia y Obesidad SC, Guadalajra

45066

Digestive Specialists Inc Research, LLC, Springboro

45070

Investigacion Biomedica para el Desarrollo de Farmacos SA de CV, Zapopan

45147

Universitaetsklinikum Essen, Essen

45219

Consultants for Clinical Research, Cincinnati

45500

University General Hospital of Ioannina, Ioannina

46635

Digestive Research Alliance of Michiana, South Bend

48098

Clinical Research Institute of Michigan, Troy

48108

Inje University Haeundae Paik Hospital, Busan

48109

University of Michigan, Ann Arbor

49519

West Michigan Clinical Research Center, Wyoming

50134

Azienda Ospedaliero Universitaria Careggi, Florence

53215

Wisconsin Center for Advanced Research, Milwaukee

54511

Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy

60590

Universitaetsklinikum Frankfurt, Frankfurt am Main

60612

Rush University Medical Center, Chicago

64060

CRI Centro Regiomontano de Investigacion SC, Monterrey

64068

Bvl Clinical Research, Liberty

64710

Hospital San Jose Tec Salud Fundacion Santos y de la Garza Evia IBP, Monterrey

65201

Gastrointestinal Associates Research, LLC, Columbia

66160

University of Kansas Medical Center, Kansas City

68100

University General Hospital of Alexandroupolis, Alexandroupoli

71409

Venizeleio General Hospital, Heraklion

71500

University Hospital of Heraklion, Heraklion

72076

Universitaetsklinikum Tuebingen, Tübingen

73102

Hightower Clinical, Oklahoma City

74104

Options Health Research, LLC, Tulsa

76301

Digestive Health Research of North Texas LLC, Wichita Falls

76712

Digestive Research of Central Texas, LLC, Waco

77024

Digestive Health Associates, Houston

79912

Great Lakes Research Insititute El Paso Research, El Paso

80054

Centre Hospitalier Universitaire Amiens Picardie, Amiens

80230

Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC, Culiacán

83404

Grand Teton Research Group, Idaho Falls

85037

Arizona Arthritis and Rheumatology Research, PLLC, Phoenix

85206

Arizona Health Research, Mesa

87106

University of New Mexico, Albuquerque

88100

Azienda Ospedaliera Universitaria Renato Dulbecco, Catanzaro

89081

Universitaetsklinikum Ulm, Ulm

89113

Interspond - Las Vegas Medical Research, Las Vegas

90035

Biopharma Informatic Incorporated, Los Angeles

90067

Gastrointestinal Biosciences Clinical Trials Limited Liability Company, Los Angeles

90720

United Medical Doctors, Los Alamitos

91360

Clinical Trials Management Services LLC, Thousand Oaks

92118

Southern California Research Center, Coronado

92200

Centres Medicaux Chirurgicaux Ambroise Pare Hartmann, Neuilly-sur-Seine

92868

University of California Irvine, Orange

93458

Santa Maria Gastroenterology Medical Group, Santa Maria

410445

Spitalul Clinic Pelican, Oradea

06518

Gastroenterology Center of Connecticut, PC, Hamden

02115

Harvard Medical School - Brigham and Womens Hospital, Boston

01655

University of Massachusetts Memorial Medical Center, Worcester

07018

Sanmora Bespoke Clinical Research Solutions, East Orange

08234

Aga Clinical Research Associates LLC, Egg Harbor

07932

Affiliates in Gastroenterology Digestive Disease Research, Florham Park

07960

Atlantic Digestive Health Institute, Morristown

07871

Premier Health Research LLC, Sparta

B7600DHK

Centro de Investigaciones Medicas Mar del Plata, Mar del Plata

B1878DVB

Cer Instituto Medico, Quilmes

B1642DSF

CardioAlem Investigaciones, San Isidro

X5000IYH

Hospital Privado Centro Medico de Cordoba SA, Córdoba

T6K 4B2

South Edmonton Gastroenterology, Edmonton

N6A 5A5

London Health Sciences Centre, University Hospital, London

M6A 3B4

TIDHI Innovation Incorporated, Toronto

500 12

Hepato-Gastroenterologie HK sro, Hradec Králové

532 03

Nemocnice Pardubickeho kraje as, Pardubicka nemocnice, Pardubice

118 00

Nemocnice Milosrdnych sester sv Karla Boromejskeho v Praze, Prague

150 00

Axon Clinical sro, Prague

401 13

Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz, Ústí nad Labem

00290

Helsinki University Central Hospital, Helsinki

06202

Centre Hospitalier Universitaire Archet 2, Nice

00157

Ospedale Sandro Pertini, Roma

277-0871

Tsujinaka Hospital Kashiwanoha, Kashiwa-shi

285-8741

Toho University Sakura Medical Center, Sakura-shi

802-8561

Kitakyushu Municipal Medical Center, Kitakyushu-shi

501-1194

Gifu University Hospital, Gifu

501-6062

Matsunami General Hospital, Hashima-gun

040-8585

Hakodate Central General Hospital, Hakodate-shi

004-0041

Sapporo Tokushukai Hospital, Sapporo

650-0015

Aoyama Clinic GI Endoscopy and IBD Center, Kobe

247-0056

Gokeikai Ofuna Chuo Hospital, Kamakura-shi

981-3213

Takagi Clinic, Sendai

880-8510

Miyazaki Prefectural Miyazaki Hospital, Miyazaki

852-8501

Nagasaki University Hospital, Nagasaki

634-8522

Nara Medical University Hospital, Kashihara-shi

701-1192

National Hospital Organization Okayama Medical Center, Okayama

545-8586

Osaka Metropolitan University Hospital, Osaka

113-8519

Tokyo Medical and Dental University Hospital, Bunkyo-ku

108-8642

Kitasato University Kitasato Institute Hospital, Minato-ku

181-8611

Kyorin University Hospital, Mitaka-shi

198-0042

Ome Medical Center, Ome-shi

171-0021

Medical Corporation ENEXT Ikebukuro West Gate Hospital, Toshima-ku

400-8506

Yamanashi Prefectural Central Hospital, Kofu

03300

Clinicos Asociados BOCM SC, Mexico City

2333 ZA

Leids Universitair Medisch Centrum, Leiden

5022 GC

Elisabeth TweeSteden Ziekenhuis, Tilburg

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

82-300

NZOZ Twoje Zdrowie EL Spzoo, Elblag

91-034

Centrum Medyczne Med-Gastr Sp zoo, Lodz

82-200

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo, Malbork

60-123

Oleg Tyszkiwski Centrum Gastrologiczne Gorczyn Oleg Tyszkiwski, Poznan

60-185

Centrum Medyczne Pratia Poznan, Skorzewo

03-712

BodyClinic spolka z ograniczona odpowiedzialnoscia, Warsaw

54-144

EuroMediCare Przychodnia Specjalistyczna we Wroclawiu, Wroclaw

50-449

Centrum Medyczne Melita Medical, Wroclaw-Krzyki

010825

Spitalul Universitar de Urgenta Militar Central Dr Carol Davila, Bucharest

012015

Clinica Medicum, Bucharest

013812

Memorial Healthcare International SRL, Bucharest

020125

Spitalul Clinic Colentina, Bucharest

022328

Institutul Clinic Fundeni, Bucharest

975 17

Fakultna Nemocnica s poliklinikou FD Roosevelta Banska Bystrica, Banská Bystrica

040 13

Endomed, sro, Košice

080 01

Gastro I, sro, Prešov

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

06800

Ankara Bilkent Sehir Hastanesi, Ankara

07100

Antalya Egitim ve Arastirma Hastanesi, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY