A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

September 13, 2022

Primary Completion Date

April 2, 2024

Study Completion Date

October 6, 2028

Conditions
Colitis, Ulcerative
Interventions
DRUG

Guselkumab Dose 1

Guselkumab (Dose 1) will be administered as SC injection.

DRUG

Guselkumab Dose 2

Guselkumab (Dose 2) will be administered as SC injection.

DRUG

Guselkumab Dose 3

Guselkumab (Dose 3) will be administered as SC injection.

OTHER

Placebo

Placebo will be administered as SC injection.

Trial Locations (235)

1000

CHU Saint-Pierre, Brussels

1023

Auckland City Hospital, Grafton

1062

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1082

Semmelweis Egyetem, Budapest

1088

Semmelweis Egyetem AOK, Budapest

1606

Medical centre Asklepion, Sofia

1680

DCC Convex EOOD, Sofia

2050

Royal Prince Alfred Hospital, Camperdown

3050

Royal Melbourne Hospital, Parkville

3168

Monash Health, Clayton

3204

Waikato Hospital, Hamilton

4025

Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont, Debrecen

4029

Royal Brisbane and Women's Hospital, Herston

4101

IBD Clinical Trials Mater Research, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

5010

Hutt Hospital, Boulcott

5011

The Queen Elizabeth Hospital, Woodville South

6150

Fiona Stanley Hospital, Murdoch

7700

Medical Center Leo Clinic EOOD, Targovishte

8011

Christchurch Hospital, Christchurch

8800

AZ Delta, Roeselare

9016

Dunedin Hospital, Dunedin

9300

Onze -Lieve-Vrouwziekenhuis, Aalst

10002

National Taiwan University Hospital, Taipei

10408

National Cancer Center, Goyang-si

10449

Mackay Memorial Hospital, Taipei

10990

Hospital Pulau Pinang, George Town

11194

The Speciality Hospital (TSH) / Advanced Clinical Center, Amman

11423

Smart Medical Research, Hollis

11942

Jordan University Hospital, Amman

14050

Hospital Médica Sur Tlalpan, Mexico City

15000

AXON Clinical s.r.o., Prague

15224

Allegheny General Hospital of Research, Pittsburgh

15355

Korea University Ansan Hospital, Gyeonggi-do

15401

Frontier Clinical Research, Uniontown

16247

The Catholic university of Korea ST Vincent Hospital, Suwon

21166

Irbid Specialty Hospital, Aydoun

21339

Staedtisches Klinikum Lueneburg, Lüneburg

22110

King Abdullah University Hospital, Irbid

23320

Gastroenterology Associates of Tidewater, Chesapeake

25020

Clinical Research Institute Saltillo S.A. de C.V., Saltillo

25030

CHRU Besancon Hopital Jean Minjoz, Besançon

27260

Peters Medical Research, High Point

29118

Gastroenterology Associates of Orangeburg, SC, Orangeburg

30309

Digestive Healthcare of Georgia, P.C, Atlanta

30342

Atlanta Gastroenterology Associates, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

30932

Polyclinique Du Grand Sud, Nîmes

31059

CHU Rangueil, Toulouse

31201

Gastroenterology Associates of Central GA, Macon

31207

SCIENTIA Investigacion Clinica SC, Chihuahua City

32806

Orlando Health, Orlando

33125

Columbus Clinical Services LLC, Miami

33176

Vista Health Research, LLC, Miami

33343

Mersin University Medical Faculty, Mersin

33604

CHU de Bordeaux - Hospital Haut-Leveque, Pessac

33762

Gastro Florida, Clearwater

34098

Istanbul University, Istanbul

34209

Theia Clincial Research, LLC, Temple Terrace

34741

I.H.S. Health. LLC, Kissimmee

35040

Ege University Medical Faculty, Izmir

37001

Nemocnice Ceske Budejovice a s, České Budějovice

39319

Praxisgemeinschaft Jerichow, Jerichow

40447

China Medical University Hospital, Taichung

40705

Taichung Veterans General Hospital, Taichung

41009

Hosp. Virgen Macarena, Seville

42270

CHU Saint Etienne Hopital Nord, Saint-Priest-en-Jarez

42415

Yeungnam University Medical Center, Daegu

44145

Gastro Intestinal Research Institute of Northern Ohio LLC, Westlake

44650

Clinica de Investigacion en Reumatologia y Obesidad, Guadalajara

45415

Dayton Gastroenterology, Inc, Dayton

47055

MVZ Sanaklinikum Duisburg, Duisburg

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48108

Inje University Haeundae Paik Hospital, Busan

48334

Detroit Clinical Research Center, Farmington Hills

50009

Hosp. Univ. Miguel Servet, Zaragoza

51092

CHU de Reims, Reims

54500

CHU Nancy Brabois, Vandœuvre-lès-Nancy

59100

University Malaya Medical Centre, Kuala Lumpur

61453

Chosun university hospital, Gwangju

64610

Centro Regiomontano de Estudios Clínicos Roma S.C., Monterrey

64710

Fundacion Santos Y De La Garza Evia IBP, Monterrey

66220

Oncare, San Pedro Garza García

66606

Cotton O'Neil Digestive Health Center, Topeka

68100

Hospital Selayang, Batu Caves

69495

Hospices Civils de Lyon HCL, Pierre-Bénite

70300

Hospital Tuanku Jaafar, Seremban

75701

Tyler Research Institute, LLC, Tyler

77407

Victoria Gastroenterology, Victoria

78229

Southern Star Research Institute, LLC, San Antonio

UT Health Science Center at San Antonio, San Antonio

80100

Hospital Sultanah Aminah, Johor Bahru

80907

Peak Gastroenterology Associates, Colorado Springs

84124

Gastroenterology Associates, Salt Lake City

84403

Care Access Research, Ogden, Ogden

85221

Medizinisches Versorgungszentrum (MVZ) Dachau, Dachau

85340

Research Solutions of Arizona, Litchfield Park

91031

Shaare Zedek Medical Center - Jerusalem, ISRAEL, Jerusalem

92123

Medical Associates Research Group, Inc., San Diego

92200

Clinique Ambroise Pare, Neuilly-sur-Seine

92307

Om Research LLC, Apple Valley

93534

Om Research LLC, Lancaster

93586

Hospital Umum Sarawak, Kuching

93624

Lev Talpiot Clinic, Jerusalem

94160

Hopital d'Instruction des Armees BEGIN, Saint-Mandé

94270

Hopital de Bicetre, Le Kremlin-Bicêtre

97070

Medical Care & Research SA de CV, Mérida

100029

China Japan Friendship Hospital, Beijing

100191

Peking University Third Hospital, Beijing

110004

Shengjing Hospital Of China Medical University, Shenyang

122002

Fortis Memorial Research Institute, Gurugram

200025

Ruijin Hospital Shanghai Jiao Tong University, Shanghai

200123

Shanghai East Hospital, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

210009

Zhongda Hospital Southeast University, Nanjing

214023

Wuxi People s Hospital, Wuxi

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

310003

The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou

310009

The Second Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou

321009

Jinhua municipal central hospital, Jinhua

341000

First Affiliated Hospital of Gannan Medical University, Ganzhou

395002

SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre, Surat

400014

Chongqing General Hospital, Chongqing

400016

P D Hinduja National Hospital and Medical Research Center, Mumbai

430060

Renmin Hospital of Wuhan University, Wuhan

442000

Taihe Hospital, Shiyan

450014

The Second Affiliated Hospital of Zhengzhou University, Zhengzhou

471003

The first affiliated hospital of Henan University of science and technology, Luoyang

500032

Asian Institute Of Gastroenterology, Hyderabad

510260

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

510280

ZhuJiang Hospital of Southern Medical University, Guangzhou

518101

Shenzhen Hospital of Southern Medical University, Shenzhen

576104

Kasturba Medical College Hospital, Manipal

610041

West China Hospital Sichuan University, Chengdu

730030

Lanzhou University Second Hospital, Lanzhou

750011

General Hospital of Ningxia Medical Hospital, Yinchuan

1040061

Ginza central clinic, Chūōku

1834111

Ha'Emek Medical Center, Afula

2210001

Galilee Medical Center, Nahariya

3339419

Bnai Zion Medical Center, Haifa

5262000

Chaim Sheba Medical Center, Ramat Gan

5822012

Wolfson Medical Center, Holon

27599-7080

University of North Carolina, Chapel Hill

B1878DVB

Cer Instituto Medico, Buenos Aires

C1221ADC

Hospital General de Agudos José Maria Ramos Mejía, Buenos Aires

C1430EGF

Clinica Adventista Belgrano, Ciudad de Buenos Aires

X5002AOQ

Sanatorio Duarte Quiroz, Córdoba

X5016KEH

Hospital Privado Universitario De Cordoba, Córdoba

B1900AXI

Hospital Italiano de La Plata, La Plata

B7600FYK

Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata

S2000KDS

Hospital Provincial del Centenario, Rosario

18618-687

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu), Botucatu

70200-730

L2IP Instituto de Pesquisas Clinicas, Brasília

13060-904

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro, Campinas

80430-180

CDC - Centro Digestivo de Curitiba, Curitiba

17201 130

CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda, Jaú

36033 318

Galileo Pesquisa Clinica, Juiz de Fora

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

90430-001

NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul, Porto Alegre

41500-300

CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao, Salvador

09080-110

Pesquisare Saude, Santo André

15015-110

Kaiser Hospta, São José do Rio Preto

01236030

BR TRIALS Ensaios Clinicos e Consultoria Ltda, São Paulo

01401-002

Instituto D Or de Pesquisa e Ensino IDOR, São Paulo

15501-405

INTEGRAL Pesquisa e Ensino, Votuporanga

V3L 3W4

Fraser Clinical Trials Inc., New Westminster

L4M 7G1

Barrie GI Associates, Barrie

S7N 0W8

Royal University Hospital, Saskatoon

050004

The Second Hospital of Hebei Medical University, Shijiazhuang

500 02

Gastroenterologie, s.r.o., Hradec Kralove, Hradec Kralova

722 00

Artroscan s r o, Ostrava

120 00

Synexus Czech s.r.o., Prague

190 00

ISCARE a.s., Prague

34295 Cedex 5

CHRU Montpellier - Hopital Saint-Eloi, Montpellier

06202

CHU de Nice Hopital de l Archet, Nice

113-8510

Tokyo Medical and Dental University Hospital, Bunkyō City

583-0027

Sai Gastroenterology Proctology, Fujiidera-shi

814 0180

Fukuoka University Hospital, Fukuoka

960 1295

Fukushima Medical University Hospital, Fukushima

031-8555

Hachinohe City Hospital, Hachinohe

192-0032

Tokai University Hachioji Hospital, Hachiōji

432 8061

Matsuda Hospital, Hamamatsu

311-3193

National Hospital Organization Mito Medical Center, Higashiibaraki-gun

890-8520

Kagoshima University Hospital, Kagoshima

892-0843

Kagoshima IBD Gastroenterology Clinic, Kagoshima

920-8650

National Hospital Organization Kanazawa Medical Center, Kanazawa

277-0871

Tsujinaka Hospital Kashiwanoha, Kashiwa

800-0296

Kyushu Rosai Hospital, Kitakyushu

360-8567

Kumagaya General Hospital, Kumagaya-shi

737-0023

National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure

270-2251

Tokushukai Chiba-Nishi General Hospital, Matsudo

399-8701

National Hospital Organization Matsumoto Medical Center, Matsumoto

460-0022

Yokoyama IBD Clinic, Nagoya

700-0013

Okayama Saiseikai General Hospital, Okayama

530-0011

Kinshukai Infusion Clinic, Osaka

543 8555

Japanese Red Cross Osaka Hospital, Osaka

870-0033

Oita Red Cross Hospital, Ōita

870-0823

Ishida Clinic of IBD and Gastroenterology, Ōita

589-8511

Kindai University Hospital, Ōsaka-sayama

321 0293

Dokkyo Medical University Hospital, Shimotsuga Gun

162 8655

Center Hospital of the National Center for Global Health and Medicine, Shinjuku Ku

130 8575

Tokyo Metropolitan Bokutoh Hospital, Sumida Ku

411-8611

National Hospital Organization Shizuoka Medical Center, Sunto-gun

279-0021

Juntendo University Hospital Urayasu, Urayasu

320-0003

Kanke Gastrointestinal Clinic, Utsunomiya

232 0024

Yokohama City University Medical Center, Yokohama

03300

Clinicos Asociados BOCM, SC, Mexico City

07369

Centro de Investigacion Clinica Acelerada S.C, Mexico City

15-322

Gastromed Kralisz Romatowski Stachurska Sp. j., Bialystok

85-168

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Bydgoszcz

89-600

Centrum Medyczne Lukamed, Chojnice

30 363

Centrum Medyczne Plejady, Krakow

31-513

Centrum Medyczne Promed, Krakow

20-582

Zespol Poradni Specjalistycznych REUMED Filia nr 2, Lublin

60 309

EMC Instytut Medyczny SA PL CERTUS, Poznan

35-326

Centrum Medyczne Medyk, Rzeszów

71-434

Twoja Przychodnia - Szczecinskie Centrum Medyczne, Szczecin

87 100

GASTROMED Sp. z o.o., Torun

03 712

Bodyclinic Sp. z o.o. sp. k, Warsaw

04 501

Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus, Warsaw

53 149

Przychodnia Vistamed, Wroclaw

53 611

Melita Medical Sp. z o.o., Wroclaw

22-400

Pro Life Medica Sp z o o ETG Zamosc, Zamość

975 17

FNsP F.D.R. Banska Bystrica, Banská Bystrica

811 09

Cliniq s.r.o., Bratislava

040 13

ENDOMED s.r.o, Košice

949 01

KM Management spol. s r.o., Nitra

03181

Kangbuk Samsung Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

06973

Chung-Ang University Hospital, Seoul

130 050

Kyung Hee University Hospital, Seoul

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

03570

Hosp. de La Marina Baixa, Villajoyosa

All Listed Sponsors
lead

Janssen Research & Development, LLC

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