A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

May 1, 2024

Primary Completion Date

June 16, 2025

Study Completion Date

June 16, 2025

Conditions
Ulcerative Colitis
Interventions
DRUG

Vixarelimab

Vixarelimab will be administered as per the schedule specified in the respective arms.

DRUG

Placebo

Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Trial Locations (122)

1000

CHU St Pierre (St Pierre), Brussels

3000

UZ Leuven, Leuven

6351

Samsung Medical Center, Seoul

10128

Azienda Ospedaliera Ordine Mauriziano di Torino, Turin

11000

Clinical Hospital Center Dragisa Misovic Dedinje, Belgrade

Military Medical Academy, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Beograd-zemun

11217

Taipei Veterans General Hospital, Taipei

12203

Charite - Campus Benjamin Franklin, Berlin

14642

Strong Memorial Hospital, Rochester

20089

Istituto Clinico Humanitas, Rozzano

20132

Ospedale San Raffaele S.r.l. - PPDS, Milan

21000

Clinical Centre of Vojvodina, Nova Sad

23000

General Hospital Djordje Joanovic - Zrenjanin, Zrenjanin

24105

Universitatsklinikum Schleswig-Holstein - Kiel, Kiel

26426

Yonsei University Wonju Severance Christian Hospital, Gangwon-do

27834

Carolina Digestive Diseases, Greenville

30342

Atlanta Gastroenterology Associates, Atlanta

31096

Rambam Health Care Campus, Haifa

31238

Hospital Angeles Chihuahua, Chihuahua City

32835

Orlando Gastroenterology, P.A., Orlando

33136

Sylvester Comprehensive Cancer Center, Miami

33155

Regenerate Primary Medical, Miami

34000

Clinical Center Kragujevac, Kragujevac

34653

Advanced Research Institute, Inc., New Port Richey

34943

The Catholic University of Korea Daejeon ST. Mary?s Hospital, Daejeon

36532

Gulf Coast Gatroenterology, Fairhope

37024

IRCCS Ospedale Sacro Cuore Don Calabria, Negrar

38671

Delta Gastroenterology & Endoscopy Center, Southaven

40138

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti, Bologna

40447

China Medical University Hospital, Taichung

41944

Kyungpook National University Hospital, Daegu

42055

CHU de Saint-Etienne - Hopital Nord, Saint-Etienne

44145

North Shore Gastroenterology, Westlake

44281

Meir Medical Center, Kfar Saba

45219

Ohio Gastroenterology and Liver Institute, Cincinnati

45645

Hospital Puerta de Hierro Sur, Tlajomulco de Zúñiga

48108

Inje university Haeundae Paik Hospital, Busan

48377

Henry Ford Health System, Novi

49267

Kosin University Gospel Hospital, Busan

52621

Sheba Medical Center - PPDS, Ramat Gan

54511

CHU de Nancy-Hopital Brabois Adulte, Vandœuvre-lès-Nancy

55905

Mayo Clinic - PPDS, Rochester

64000

Accelerium, S. de R.L. de C.V. - PPDS, Monterrey

69310

Hospices Civils de Lyon Centre hospitalier Lyon Sud, Pierre-Bénite

75701

Tyler Research Institute, LLC, Tyler

82445

E-Da Hospital, Kaohsiung City

83301

Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital, Niaosong Dist.

84132

University of Utah - Health Sciences Center - PPDS, Salt Lake City

89081

Universitaetsklinikum Ulm, Ulm

90095

UCLA Clinical and Translational Research Center, Los Angeles

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

93012

OM Research LLC - Camarillo - ClinEdge - PPDS, Camarillo

97070

Medical Care & Research SA de CV, Mérida

110004

Shengjing Hospital of China Medical University, Shenyang

214023

Wuxi People's Hospital, Wuxi

215006

The First Affiliated Hospital of Soochow University, Suzhou

250012

Qilu Hospital of Shandong University, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

315000

The First Affiliated Hospital of Ningbo University(Ningbo First Hospital), Ningbo

321000

Jinhua municipal central hospital, Jinhua

430023

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

510080

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

510655

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

610047

West China Hospital - Sichuan University, Chengdu

750004

General Hospital of Ningxia Medical University, Yinchuan

91345 1116

Facey Medical Foundation - Mission Hills, Mission Hills

92103-5639

Clinical Applications Laboratories, Inc., San Diego

60637-1426

University of Chicago Medical Center, Chicago

41500-300

Cliagen Clinica de Atençao em Gastroenterologia, Especialidades e Nutriçao, Salvador

70200-730

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME, Brasília

80430-160

Centro Digestivo de Curitiba, Curitiba

90035-903

Hospital de Clinicas de Porto Alegre HCPA PPDS, Pôrto Alegre

90035-001

Associacao Hospitalar Moinhos de Vento, Porto Alegre

18618-687

Hospital das Clinicas da Faculdade de Medicina de Botucatu (HCFMB), Botucatu

17201-130

Centro de Estudos Clinicos do Interior Paulista, Jaú

09080-110

Pesquisare Saude, Santo André

09090-790

Praxis Pesquisa Médica, Santo André

15015-110

Kaiser Hospital Dia, São José do Rio Preto

01308-050

Hospital Sirio-Libanes, São Paulo

21941-913

Hospital Universitario Clementino Fraga Filho - UFRJ, Rio de Janeiro

Unknown

The First Affiliated Hospital of Nanchang University, Nanchang

050000

The Second Hospital of Hebei Medical University, Shijiazhuang

602 00

SurGal Clinic s.r.o., Brno

500 12

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

779 00

PreventaMed s.r.o., Olomouc

150 00

Endohope klinika s. r.o., Prague

06202

CHU Nice - Hopital de l'Archet 2, Nice

06120

Universitaetsklinikum Halle (Saale), Halle

106 76

Evangelismos General Hospital of Athens, Athens

115 27

Sotiria General Hospital of Athens, Athens

115 28

Alexandra Hospital, Athens

711 10

University General Hospital of Heraklion, Heraklion

175 62

Iatriko Palaiou Falirou, Palaió Fáliro

185 36

Tzaneio General Hospital, Piraeus

00168

Fondazione Policlinico Universitario A Gemelli-Rome, Rome

09042

Azienda Ospedaliero - Universitaria di Cagliari, Monserrato

53-611

Melita Medical Sp. Z O. O., Wroclaw

54-144

EuroMediCare Szpital Specjalistyczny z Przychodni? we Wroc?awiu, Wroclaw

92-213

Clinical Trials UMED Sp. z o. o., ?ód?

93-357

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o., ?ód?

85-231

Medical Center Kermed, Bydgoszcz

25-355

Polimedica PTG Kielce, Kielce

44-190

MZ Badania Slowik Zymla Sp.j., Knurów

31-506

Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna, Krakow

34-400

Allmedica Badania Kliniczne sp. z o.o. sp.k., Nowy Targ

05-400

Office of Jaroslaw Kierkus, Dr n Med, Otwock

81-756

Endoskopia Sp. z o.o., Sopot

71-685

Sonomed Sp. z o.o., Szczecin

33-100

Centrum Medyczne UNO-MED-Tarnow, Tarnów

34-100

NZOZ FORMED sp zo.o., Wadowice

00-635

Centrum Zdrowia MDM, Warsaw

03-580

Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED, Warsaw

52-210

PlanetMed, Wroc?aw

53-149

Przychodnia VISTAMED, Wroc?aw

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System - PPDS, Seoul

00100

National Taiwan University Hospital, Taipei

E1 4AT

The Royal London Hospital, London

W12 0HS

Hammersmith Hospital, London

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY