AzTrials
AzTrials

Ulcerative ColitisPhase 2/3QUASARNCT04033445

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

A Phase 2/3 study testing Guselkumab in people with Ulcerative Colitis, run by Janssen Research & Development, LLC at 392 sites in 34 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,064 participants
Where
392 sitesin 34 countries
Study dates
26 Sep 2019to 16 Jul 2027
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of ulcerative colitis (UC)
  • Moderately to severely active UC, defined by modified Mayo score
  • Demonstrated inadequate response or intolerance to medical therapies specified in the protocol
  • Screening laboratory test results within the parameters specified in the protocol

Who cannot join

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease
  • UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
  • Presence of a stoma
  • Presence or history of a fistula
  • Receiving prohibited medications and/or treatment

Trial locations and contacts

392 sites in 34 countries.

392 sites in 34 countries

Japan74 sites

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

  • Juntendo University Hospital Urayasu

    Chiba, 279 0021

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Ehime Prefectural Central Hospital

    Ehime, 790-0024

  • Sai Gastroenterology Proctology

    Fujiidera-shi, 583-0027

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Kitakyushu Municipal Medical Center

    Fukuoka-ken, 802-0077

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Gifu University Hospital

    Gifu, 501-1194

  • Hachinohe City Hospital

    Hachinohe, 031-8555

  • Tokai University Hachioji Hospital

    Hachiōji, 192-0032

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611

  • Matsuda Hospital

    Hamamatsu, 432-8061

  • Matsunami General Hospital

    Hashima-gun, 501-6062

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, 036-8545

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • Kure Kyosai Hospital

    Hiroshima, 737-8505

  • Asahikawa Medical University Hospital

    Hokkaido, 078 8510

  • Mito Saiseikai General Hospital

    Ibaraki, 311-4198

  • Shimane University Hospital

    Izumo, 693-8501

  • Imamura General Hospital

    Kagoshima, 890-0064

  • Kagoshima University Hospital

    Kagoshima, 890-8544

  • Izuro Imamura Hospital

    Kagoshima, 892-0824

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • Sameshima Hospital

    Kagoshima, 892-0846

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Matsushima Hospital

    Kanagawa, 220-0041

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • The Jikei University Kashiwa Hospital

    Kashiwa, 277 -8567

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • Kyushu Rosai Hospital

    Kitakyushu, 800-0296

  • Kobe University Hospital

    Kobe, 650 0017

  • Aoyama Naika Clinic

    Kobe, 650-0015

  • National Hospital Organization Kochi National Hospital

    Kochi, 780-8077

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Kumagaya General Hospital

    Kumagaya-shi, 360-8567

  • National Hospital Organization Kure Medical Center and Chugoku Cancer Center

    Kure, 736-0023

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • National Hospital Organization Matsumoto Medical Center

    Matsumoto, 399-8701

  • National Hospital Organization Tokyo Medical Center

    Meguro Ku, 152 8902

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Takagi Clinic

    Miyagi, 981-3213

  • Iwate Medical University Uchimaru Medical Center

    Morioka, 020-8505

  • Nagoya University Hospital

    Nagoya, 466 8560

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Nagaoka Chuo General Hospital

    Niigata, 940-8653

  • Hyogo Medical University Hospital

    Nishinomiya Shi, 663 8501

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Shinbeppu Hospital

    Ōita, 874-8538

  • Nakagami Hospital

    Okinawa, 904-2195

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555

  • Osaka Metropolitan University Hospital

    Osaka, 545 8586

  • Izumiotsu Municipal Hospital

    Osaka, 595-0027

  • Osaki Citizen Hospital

    Ōsaki, 989-6183

  • Japan Community Health Care Organization Saitama Medical Center

    Saitama, 330-0074

  • Kindai University Hospital

    Sakai, 590 0197

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Sapporo, 060-0033

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

  • Sapporo IBD Clinic

    Sapporo, 064-0919

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • Tokushima University Hospital

    Tokushima, 770-8503

  • The Jikei University Hospital

    Tokyo, 105 8471

  • Mie University Hospital

    Tsu, 514-8507

  • Yokkaichi Hazu Medical Center

    Yokkaichi, 510-0016

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221 0855

  • University of Fukui Hospital

    Yoshida, 910-1193

Other trials in Japan

United States52 sites

  • Synexus Clinical Research US Inc 1

    Anderson, South Carolina, 29621-2062

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30224

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Atlanta Gastroenterology Associates 1

    Atlanta, Georgia, 30342

  • Care Access Research, Casper

    Casper, Wyoming, 10456

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • University of Chicago

    Chicago, Illinois, 60637

  • Clinical Research Institute of Michigan, LLC

    Clinton Township, Michigan, 48038

  • Peak Gastroenterology Associates 1

    Colorado Springs, Colorado, 80907

  • Synexus Clinical Research US Inc

    Columbus, Ohio, 43212

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

  • Atlanta Center For Gastroenterology

    Decatur, Georgia, 30033

  • Revive Research Institute

    Farmington Hills, Michigan, 48334

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • University of Florida Health Jacksonville

    Gainesville, Florida, 32608

  • Infusion Associates

    Grand Rapids, Michigan, 49525

  • Harmony Medical Research Institute, Inc.

    Hialeah, Florida, 33016

  • Baylor College of Medicine

    Houston, Texas, 77030

  • UF Health Jacksonville Gastroenterology Emerson

    Jacksonville, Florida, 32209

  • Mid-America Gastro-Intestinal Consultants

    Kansas City, Missouri, 64111

  • I.H.S. Health. LLC

    Kissimmee, Florida, 34741

  • Om Research LLC

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • UCLA

    Los Angeles, California, 90095

  • Caprock Gastro Research

    Lubbock, Texas, 79424

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia, 31201

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Vista Health Research, LLC

    Miami, Florida, 33155

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Care Access Research, Ogden

    Ogden, Utah, 84403

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73114

  • Gastroenterology Associates of Orangeburg, SC

    Orangeburg, South Carolina, 29118

  • Orlando Health

    Orlando, Florida, 32806

  • Care Access Research, Orlando

    Orlando, Florida, 32825

  • Synexus Clinical Research US Inc 2

    Pinellas Park, Florida, 33781

  • Health Science Research Center

    Pratt, Kansas, 67124

  • Duke University Hospital Medical Center

    Raleigh, North Carolina, 27609

  • Care Access Research- Salt Lake City

    Salt Lake City, Utah, 84124

  • UW-Harborview Medical Center

    Seattle, Washington, 98104

  • Providence Medical Group

    Spokane, Washington, 99208

  • Velocity Clinical Research Spokane

    Spokane, Washington, 99218

  • Digestive Specialists, Inc

    Springboro, Ohio, 45066

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Barnes-jewish Hospital

    St Louis, Missouri, 63108

  • Univ. of South Florida Med. Group

    Tampa, Florida, 33606

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Gastro Intestinal Research Institute of Northern Ohio LLC

    Westlake, Ohio, 44145

  • US Digestive Health

    Wyomissing, Pennsylvania, 19610

  • Care Access Research, Poland

    Youngstown, Ohio, 44514

Other trials in United States

China28 sites

  • Capital Medical University, Beijing Friendship Hospital

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • China-Japan Union Hospital of Jilin University

    Changchun, 130033

  • The second Xiangya Hospital of Central South University

    Changsha, 200120

  • The Third Xiangya Hospital of Central Sourth University

    Changsha, 40013

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Daping Hospital

    Chongqing, 400042

  • The Second Hospital To Dalian Medical University

    Dalian, 116027

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341000

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510610

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003

  • The Second Affiliated Hospital of Zhejiang University

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • First Affiliated Hospital of Kunming Medical Unversity

    Kunming, 650032

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • Jiangsu Province Hospital

    Nanjing, 210029

  • Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

    Shanghai, 200025

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • The Second Hospital Affiliated To Suzhou University

    Suzhou, 215168

  • The first affiliated hospital of suzhou University

    Suzhou

  • Tianjin Medical University General Hospital

    Tianjin, 300011

  • Wuhan Union Hospital

    Wuhan, 430022

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030

  • Wuxi People s Hospital

    Wuxi, 214023

Other trials in China

Russia18 sites

  • Immanuel Kant Baltic Federal University

    Kaliningrad, 236016

  • Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways

    Nizhny Novgorod, 603140

  • Medical Center SibNovoMed LLC

    Novosibirsk, 630005

  • LLC 'Novosibirsk Gastrocentr'

    Novosibirsk, 630007

  • City Clinical Hospital #2

    Perm, 614068

  • Rostov State Medical University 1

    Rostov-on-Don, 344022

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • International Medical Centre SOGAZ

    Saint Petersburg, 191186

  • All-Russian Center of Emergency and Radiation Medicine MCRS

    Saint Petersburg, 194044

  • Eco-safety Ltd

    Saint Petersburg, 196143

  • Medical University Reaviz

    Samara, 443001

  • NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

    Samara, 443041

  • Saratov Regional Clinical Hospital

    Saratov, 410053

  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

    Ufa, 450005

  • City Clinical Hospital # 21

    Ufa, 450071

  • Regional Clinical Hospital 1

    Yaroslavl, 150062

  • Medical Center Meditsinskie Tekhnologii

    Yekaterinburg, 620075

  • OOO MO New Hospital

    Yekaterinburg, 620109

Other trials in Russia

Poland16 sites

  • Gastromed Kralisz Romatowski Stachurska Sp. j.

    Bialystok, 15-322

  • Centrum Medyczne Medis

    Bydgoszcz, 85 229

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Promed

    Krakow, 31-513

  • Gastromed ZOZ

    Lublin, 20-583

  • Medicome Sp z o.o.

    Oświęcim, 32-600

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • Uromed Jakub Koteras Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • GASTROMED Sp. z o.o.

    Torun, 87 100

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw, 02-507

  • Wojskowy Instytut Medyczny

    Warsaw, 04 349

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

  • Wro Medica

    Wroclaw, 51-685

  • Melita Medical Sp. z o.o.

    Wroclaw, 53 611

  • ETG Zamosc

    Zamość, 22 400

Other trials in Poland

Brazil14 sites

  • L2IP Instituto de Pesquisas Clinicas

    Brasília, 70200 730

  • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

    Campinas, 13060-904

  • CDC - Centro Digestivo de Curitiba

    Curitiba, 80430-180

  • Galileo Pesquisa Clinica

    Juiz de Fora, 36033 318

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430-001

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 21941-913

  • CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

    Salvador, 41500-300

  • CPQuali Pesquisa Clinica LTDA ME

    São Paulo, 01228-900

  • BR Trials

    São Paulo, 01236030

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 01401 002

  • Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

    Teresina, 64049-550

  • Eurolatino Pesquisas Medicas Ltda

    Uberlândia, 38400-368

Other trials in Brazil

South Korea13 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Yeungnam University Hospital

    Daegu, 42415

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • KyungHee University Hospital

    Seoul, 02447

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Ukraine13 sites

  • Municipal Non-Profit Enterprise Ivano Frankivsk Regional Clinical Hospital

    Ivano-Frankivsk, 76008

  • Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'

    Kharkiv, 61037

  • SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039

  • Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'

    Kherson, 73003

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091

  • MC PE Sygma

    Kyiv, 04116

  • Limited Liability Company Progastro Clinic

    Lviv, 79019

  • Kalyna Center of Modern Medicine

    Lviv, 79034

  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

    Odesa, 65025

  • Sumy Regional Clinical Hospital a Non-profit Enterprise of Sumy Regional Council

    Sumy, 40022

  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil, 46002

  • Health Clinic Limited Liability Company

    Vinnytsia, 21009

  • Municipal Non-Profit Enterprise M I Pyrohov Vinnytsia Regional Clinical Hospital

    Vinnytsia, 21018

Other trials in Ukraine

Czechia12 sites

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 37001

  • Asclepiades Interna a Gastroenterologie s r o

    Havířov, 73601

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

    Hradec Kralova, 500 02

  • MUDr. Gregar s.r.o.

    Olomouc, 779 00

  • Vitkovicka nemocnice a.s.

    Ostrava, 703 84

  • Artroscan s r o

    Ostrava, 722 00

  • Synexus Czech s.r.o.

    Prague, 120 00

  • ResTrial GastroEndo, s.r.o

    Prague, 143 00

  • Nemocnice na Homolce

    Prague, 150 30

  • AXON Clinical s.r.o.

    Prague, 15000

  • ISCARE a.s.

    Prague, 190 00

  • Nemocnice Strakonice, a.s.

    Strakonice, 386 29

Other trials in Czechia

France12 sites

  • CHU caen

    Caen, 14033

  • Hopital Beaujon

    Clichy, 92110

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59000

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU de Nice Hopital de l Archet

    Nice, 62002

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Haut-Leveque, CMC Magellan

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • CHU Rangueil

    Toulouse, 31059

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Turkey (Türkiye)12 sites

  • Hacettepe University Hospital

    Ankara, 06230

  • Gazi University Hospital

    Ankara, 06560

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Medicana International Istanbul

    Istanbul, 34520

  • BAU Medical Park Goztepe Hospital

    Istanbul, 34732

  • Acibadem Kozyatagi Hospital

    Istanbul, 34734

  • Ege University Medical Faculty

    Izmir, 35100

  • Dokuz Eylul University Medical Faculty

    Izmir, 35330

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Mersin University Medical Faculty Hospital

    Mersin, 33110

Other trials in Turkey (Türkiye)

Argentina11 sites

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

    Buenos Aires, 1431

  • Cer Instituto Medico

    Buenos Aires, 1878

  • CINME Centro de Investigaciones Metabolicas

    Buenos Aires, C1056ABI

  • Hospital General de Agudos José Maria Ramos Mejía

    Buenos Aires, C1221ADC

  • Centro Médico Dra. De Salvo

    Caba, C1426ABP

  • Clinica Adventista Belgrano

    Ciudad de Buenos Aires, C1430EGF

  • Sanatorio Duarte Quiroz

    Córdoba, X5002AOQ

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Fundacion de Estudios Clinicos

    Rosario, 2000

  • Hospital Provincial del Centenario

    Rosario, S2000KDS

  • Hospital de Alta Complejidad en Red 'El Cruce'

    San Juan Bautista, 1888

Other trials in Argentina

Italy11 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

    Negrar, 37024

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Azienda Ospedaliera G.Salvini Ospedale di Rho

    Rho

  • Università Campus Biomedico di Roma

    Roma, 00128

  • Fondazione Policlinico Gemelli Università Cattolica

    Roma, 00168

  • Istituto Clinico Humanitas Rozzano, IRCCS

    Rozzano, 20089

  • Casa Sollievo Della Sofferenza IRCCS

    San Giovanni Rotondo, 71013

  • AO Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Hungary9 sites

  • Synexus Magyarorszag Kft

    Budapest, 1036

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis University 1

    Budapest, 1082

  • Semmelweis University

    Budapest, 1088

  • Vasutegeszsegugyi Nonprofit Kozhasznu Kft

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, H-4032

  • Gyongyosi Bugat Pal Korhaz

    Gyöngyös, 3200

  • Synexus Magyarorszag Kft 1

    Gyula, 5700

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika

    Szeged, 6725

Other trials in Hungary

Australia8 sites

  • Emeritus Research

    Camberwell, 3124

  • Monash Health

    Clayton, 3168

  • Western Health

    Footscray, 3011

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Royal Perth Hospital

    Perth, 6000

  • Mater Hospital

    South Brisbane, 4101

  • St John of God Subiaco Hospital

    Subiaco, 6008

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Bulgaria8 sites

  • Medical Centre Asklepii OOD

    Dupnitsa, 2600

  • Medical Center-1-Sevlievo EOOD

    Sevlievo, 5400

  • 2-nd MHAT

    Sofia, 1202

  • 4th MHAT - Sofia

    Sofia, 1606

  • DCC Convex EOOD

    Sofia, 1680

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

    Sofia, 1784

  • MHAT 'St. Marina' EAD

    Varna, 9010

  • MHAT Dr Stefan Cherkezov

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Belgium7 sites

  • AZ Sint Lucas 1

    Bruges, 8310

  • CHU Saint-Pierre

    Brussels, 1000

  • Hopital Erasme

    Brussels, 1070

  • AZ Maria Middelares

    Ghent, 9000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Algemeen Ziekenhuis Jan Palfijn Merksem

    Merksem, 2170

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Germany7 sites

  • Universitaetsklinikum Charite, Campus Virchow Klinikum

    Berlin, 13353

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Israel7 sites

  • Rambam Medical Center

    Haifa, 31096

  • Bnai Zion Medical Center

    Haifa, 3449419

  • Wolfson Medical Center

    Holon, 58100

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Lev Talpiot Clinic

    Jerusalem, 93624

  • Galilee Medical Center

    Nahariya, 2210001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423914

Other trials in Israel

Slovakia7 sites

  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica, 975 17

  • Gastroenterology Department GASTROMART s.r.o.

    Bardejov, 085 01

  • Gastroenterology Center ASSIDUO

    Bratislava, 811 08

  • Cliniq s.r.o.

    Bratislava, 811 09

  • ENDOMED s.r.o

    Košice, 040 13

  • GASTRO I. s.r.o.

    Prešov, 080 01

  • Accout Center, s.r.o., Gastroenterologická ambulancia

    Šahy, 93601

Other trials in Slovakia

Spain7 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Ntra. Sra. de Valme

    Seville, 41014

Other trials in Spain

Canada6 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

  • G I R I GI Research Institute Foundation

    Vancouver, British Columbia, V6Z 2K5

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Jordan5 sites

  • Jordan University Hospital

    Amman, 11942

  • Istishari Hospital

    Amman

  • Khalidi Hospital and Medical Center

    Amman

  • Irbid Specialty Hospital

    Irbid, 21166

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Portugal5 sites

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099 001

  • Uls Sao Joao - Hosp. Sao Joao

    Porto, 4200 319

  • Uls de Entre Douro E Vouga - Hosp. Sao Sebastiao

    Santa Maria da Feira, 4520-211

  • Centro Hospitalar de Tondela Viseu, EPE

    Viseu, 3504-509

Other trials in Portugal

Latvia4 sites

  • Pauls Stradins Clinical University Hospital 1

    Riga, LV-1002

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

  • Health Centre 4 Centre of Diagnostics

    Riga, LV1003

  • Digestive Diseases Centre GASTRO

    Riga, LV1079

Other trials in Latvia

Malaysia4 sites

  • Hospital Serdang

    Kajang, 43000

  • Hospital University Sains Malaysia

    Kelantan, 16150

  • Pusat Perubatan Universiti Kebangsaan Malaysia

    Kuala Lumpur, 56000

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Taiwan4 sites

  • Chang-Hua Christian Hospital

    Changhua, 50006

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 33305

Other trials in Taiwan

Ireland3 sites

  • Beaumont Hospital

    Dublin, 9

  • St Vincent's University Hospital

    Dublin, D04T6F4

  • University Hospital Galway - Ireland

    Galway, H91YR71

Other trials in Ireland

Netherlands3 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 AC

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Radboudumc

    Nijmegen, 6525 GA

Other trials in Netherlands

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland City Hospital

    Grafton, 1023

  • Waikato Hospital

    Hamilton, 3204

Other trials in New Zealand

Serbia3 sites

  • Zvezdara University Medical Center

    Belgrade, 11000

  • General Hospital 'Dr Radivoj Simonovic'

    Sombor, 25101

  • General Hospital 'Djordje Joanovic'

    Zrenjanin, 23000

Other trials in Serbia

United Kingdom3 sites

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Guy's and St Thomas' Hospital

    London, SE1 7EH

  • St Georges Hospital

    London, SW17 0QT

Other trials in United Kingdom

Sweden2 sites

  • Karolinska Universitetssjukhuset

    Stockholm, SE-171 76

  • Uppsala University

    Uppsala, SE 75185

Other trials in Sweden

Austria1 site

  • Universitaetsklinikum Salzburg Landeskrankenhaus

    Salzburg, 5020

Other trials in Austria

About this study

Official title: CNTO1959UCO3001: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Being tested
Placebo, Guselkumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Participants will receive matching placebo IV or SC.

  • GuselkumabDrug

    Participants will receive guselkumab IV or SC.

Study groups in NCT04033445
Study groupRoleWhat they receive
Induction Study 1: Guselkumab Dose 1ExperimentalParticipants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
Receives: Drug: Guselkumab
Induction Study 1: Guselkumab Dose 2ExperimentalParticipants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
Receives: Drug: Guselkumab
Induction Study 1: Placebo IVPlacebo comparatorParticipants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
Receives: Drug: Placebo
Induction Study 2: Guselkumab IVExperimentalParticipants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.
Receives: Drug: Guselkumab
Induction Study 2: Placebo IVPlacebo comparatorParticipants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.
Receives: Drug: Placebo
Maintenance Study: Maintenance Dose Regimen 1ExperimentalParticipants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).
Receives: Drug: Guselkumab
Maintenance Study: Maintenance Dose Regimen 2ExperimentalParticipants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).
Receives: Drug: Guselkumab
Maintenance Study: Placebo SCPlacebo comparatorParticipants will receive matching placebo SC q4w.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

    Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

    Measured: At Week I-12

  2. Induction Study 2: Percentage of Participants With Clinical Remission at Week I-12

    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

    Measured: At Week I-12

  3. Maintenance Study: Percentage of Participants With Clinical Remission at Week M-44

    Clinical remission was based on the modified Mayo score. Clinical remission was defined as Mayo stool frequency subscore of 0 or 1 and not increased from baseline (Week 0 of IS-1 and IS-2), a Mayo rectal bleeding subscore of 0, and Mayo endoscopic subscore of 0 or 1 with no friability. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for randomized arms only.

    Measured: At Week M-44

Secondary outcomes (23)

  1. Induction Study 1: Percentage of Participants With Clinical Remission at Week I-12

    Measured: At Week I-12

  2. Induction Study 1: Percentage of Participants With Symptomatic Remission at Week I-12

    Measured: At Week I-12

  3. Induction Study 1: Percentage of Participants With Endoscopic Healing at Week I-12

    Measured: At Week I-12

  4. Induction Study 1: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

    Measured: At Week I-12

  5. Induction Study 1: Percentage of Participants With Endoscopic Normalization at Week I-12

    Measured: At Week I-12

  6. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-12

    Measured: At Week I-12

  7. Induction Study 2: Percentage of Participants With Endoscopic Healing at Week I-12

    Measured: At Week I-12

  8. Induction Study 2: Percentage of Participants With Clinical Response at Week I-12

    Measured: At Week I-12

  9. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-4

    Measured: At Week I-4

  10. Induction Study 2: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12

    Measured: At Week I-12

  11. Induction Study 2: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week I-12

    Measured: At Week I-12

  12. Induction Study 2: Percentage of Participants With Fatigue Response at Week I-12

    Measured: At Week I-12

  13. Induction Study 2: Percentage of Participants With Symptomatic Remission at Week I-2

    Measured: At Week I-2

  14. Induction Study 2: Percentage of Participants With Endoscopic Normalization at Week I-12

    Measured: At Week I-12

  15. Maintenance Study: Percentage of Participants With Symptomatic Remission at Week M-44

    Measured: At Week M-44

  16. Maintenance Study: Percentage of Participants With Endoscopic Healing at Week M-44

    Measured: At Week M-44

  17. Maintenance Study: Percentage of Participants With Corticosteroid-free Clinical Remission at Week M-44

    Measured: At Week M-44

  18. Maintenance Study: Percentage of Participants With Clinical Response at Week M-44

    Measured: At Week M-44

  19. Maintenance Study: Percentage of Participants With Histologic-Endoscopic Mucosal Healing at Week M-44

    Measured: At Week M-44

  20. Maintenance Study: Percentage of Participants With IBDQ Remission at Week M-44

    Measured: At Week M-44

  21. Maintenance Study: Percentage of Participants With Fatigue Response at Week M-44

    Measured: At Week M-44

  22. Maintenance Study: Percentage of Participants With Clinical Remission at Week 44 Among the Participants Who Had Achieved Clinical Remission at Maintenance Baseline

    Measured: At Week M-44

  23. Maintenance Study: Percentage of Participants With Endoscopic Normalization at Week M-44

    Measured: At Week M-44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start26 Sep 2019
  3. Primary completion19 Sep 2023
  4. Study completion16 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,064 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04033445
Sponsor's protocol ID
CR108657
Other IDs
CNTO1959UCO3001, 2018-004002-25, 2023-504718-31-00, 2023, 2018
Acronym
QUASAR
Status last verified
Sep 2026
First submitted
24 Jul 2019
Last updated
28 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

  • Lichtenstein GR, Allegretti JR, Rubin DT, Magro F, Bressler B, Panes J, Afif W, Samaan MA, Ye BD, Yarandi S, Germinaro M, Shipitofsky N, Miao Y, Zhang H, Dignass A, Sands BE, Hisamatsu T, Peyrin-Biroulet L. Efficacy and Safety of Guselkumab for Ulcerative Colitis Through Week 92 of the QUASAR Long-Term Extension Study. Am J Gastroenterol. 2026 May 1. doi: 10.14309/ajg.0000000000004041. Online ahead of print.

    PubMed 42065421

  • Hart A, Sridhar S, Venkat S, Lee T, Rusbuldt JJ, Richards D, Sisk C, Horowitz D, Tomsho L, Kannan AK, Ruane D, Van den Berge K, Rubin DT, Sands BE, De Hertogh G, Huang KG, Germinaro M, Cua D, Waterworth D, Freeman TC, Vetter ML, McRae B, Verstockt B, Branigan P. Multiomic characterisation of the clinical efficacy of guselkumab induction therapy in ulcerative colitis. BMJ Open Gastroenterol. 2026 Mar 23;13(1):e002153. doi: 10.1136/bmjgast-2025-002153.

    PubMed 41871904

  • Chen B, Ye BD, Cao Q, Hirai F, Saruta M, Chen M, Pelak S, Shipitofsky N, Miao Y, Herr K, Wahking B, Zhuo J, Hisamatsu T. Guselkumab in East Asians With Moderate-to-Severe Ulcerative Colitis: Subgroup Analysis of the QUASAR Induction and Maintenance Studies. J Gastroenterol Hepatol. 2025 Sep;40(9):2197-2208. doi: 10.1111/jgh.17036. Epub 2025 Jun 26.

    PubMed 40574492

  • Rubin DT, Allegretti JR, Panes J, Shipitofsky N, Yarandi SS, Huang KG, Germinaro M, Wilson R, Zhang H, Johanns J, Feagan BG, Hisamatsu T, Lichtenstein GR, Bressler B, Peyrin-Biroulet L, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies. Lancet. 2025 Jan 4;405(10472):33-49. doi: 10.1016/S0140-6736(24)01927-5. Epub 2024 Dec 17.

    PubMed 39706209

  • Peyrin-Biroulet L, Allegretti JR, Rubin DT, Bressler B, Germinaro M, Huang KG, Shipitofsky N, Zhang H, Wilson R, Han C, Feagan BG, Sandborn WJ, Panes J, Hisamatsu T, Lichtenstein GR, Sands BE, Dignass A; QUASAR Study Group. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1.

    PubMed 37659673

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Guselkumab in people with Ulcerative Colitis, run by Janssen Research & Development, LLC at 392 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 392 sites in Japan, United States, China, Russia, Poland and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12 (time frame: At Week I-12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04033445, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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