AzTrials
AzTrials

Crohn's DiseasePhase 2DUET-CDNCT05242471

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 2 study testing Guselkumab, Golimumab and JNJ-78934804 in people with Crohn's Disease, run by Janssen Research & Development, LLC at 456 sites in 36 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 of JNJ-78934804 at Week 48 compared to guselkumab and golimumab. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Crohn's Disease
What is being tested?
Guselkumab, Golimumab and JNJ-78934804
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
703 participants
Where
456 sitesin 36 countries
Study dates
22 Jul 2022to 5 Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by Crohn'

Who cannot join

None listed.

Trial locations and contacts

456 sites in 36 countries.

456 sites in 36 countries

United States90 sites

  • Om Research LLC

    Apple Valley, California, 92307

  • Valley Gastroenterology Medical Group

    Arcadia, California, 91006

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University of Mississippi Medical Center

    Atlanta, Georgia, 30342

  • University of Colorado

    Aurora, Colorado, 80045

  • Amel Med LLC Research

    Austin, Texas, 78750

  • Washington Gastroenterology, PLLC

    Bellevue, Washington, 98004

  • University of Alabama Liver Center

    Birmingham, Alabama, 35233

  • Lahey Hospital & Medical Center

    Boston, Massachusetts, 02215-5400

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7080

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Tryon Medical Group

    Charlotte, North Carolina, 28210

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Brigham And Women's Hospital

    Chestnut Hill, Massachusetts, 02467

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195-6501

  • Pioneer Research Solutions Inc.

    Coconut Creek, Florida, 33066

  • Southern California Research Center

    Coronado, California, 92118

  • Tri-State Gastroenterology Assoc

    Crestview Hills, Kentucky, 41017

  • Baylor University Medical Center

    Dallas, Texas, 75242

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9063

  • Gastrointestinal Associates LLP

    Flowood, Mississippi, 39232

  • Saint Francis Hospital

    Germantown, Tennessee, 38138

  • Northwell Health

    Great Neck, New York, 11021

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06518

  • Susquehanna Gastroenterology Associates

    Harrisburg, Pennsylvania, 17110-3673

  • Galen Medical Group

    Hixson, Tennessee, 37343

  • Homestead Associates in Research Inc

    Homestead, Florida, 33032

  • Accurate Clinical Research

    Houston, Texas, 77034

  • Marshall Health Clinical Research Center

    Huntington, West Virginia, 25701

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • A1 Clinical Research

    Jackson Heights, New York, 11372

  • Etsu Quillen College Of Medicine

    Johnson City, Tennessee, 37604

  • Osceola Mental Health D/B/A Park Place Behavioral Health Care

    Kissimmee, Florida, 34741

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

  • Florida Research Center Inc.

    Lakewood Rch, Florida, 34211

  • Desert Gastroenterology Associates

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Care Access Las Vegas

    Las Vegas, Nevada, 89148

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Moore Clinical Trials, LLC

    Little Rock, Arkansas, 72205

  • Detroit Clinical Research Center

    Livonia, Michigan, 48152

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Gastroenterolgy Associates of Central GA

    Macon, Georgia, 31201

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • University of Miami Hospital

    Miami, Florida, 33136

  • Gastroenterology Group Of Naples

    Naples, Florida, 34102

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37067

  • Gastroenterology of Southern Indiana

    New Albany, Indiana, 47150

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Weill Cornell Medical College

    New York, New York, 10021

  • Lenox Hill Hospital

    New York, New York, 10075

  • Hoag Memorial Hospital

    Newport Beach, California, 92658

  • Care Access Research, Ogden

    Ogden, Utah, 84403

  • UCI Irvine Medical Center

    Orange, California, 92868

  • Omega Research Consultants

    Orlando, Florida, 32808

  • University of Pennsylvania - Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

  • The Oregon Clinic

    Portland, Oregon, 97220-9428

  • Hunter Holmes McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • Digestive Disease Associates

    Rock Hill, South Carolina, 29732

  • Care Access Research- Salt Lake City

    Salt Lake City, Utah, 84124

  • Gastroenterology Clinic Of San Antonio P A

    San Antonio, Texas, 78229

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • University of California San Francisco

    San Francisco, California, 94115

  • Swedish Medical Center

    Seattle, Washington, 98104

  • University of Washington Digestive Disease Center

    Seattle, Washington, 98195

  • Frontier Clinical Research

    Smithfield, Pennsylvania, 15478

  • FC Research, LLC

    South Dartmouth, Massachusetts, 02747

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington University

    St Louis, Missouri, 63110

  • Synergy Clinical Research

    St. Petersburg, Florida, 33705

  • Digestive Health Specialists 1

    Tacoma, Washington, 98405

  • GCP Clinical Research

    Tampa, Florida, 33609

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715

  • Digestive Health Specialists

    Tyler, Texas, 75701

  • Mohawk Valley Endoscopy Center

    Utica, New York, 13502-6313

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Northshore Gastroenterology Research, LLC

    Westlake, Ohio, 44145

  • Ascension via Christi Research

    Wichita, Kansas, 67208

  • Univ. of KS School of Med

    Wichita, Kansas, 67214-3124

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Huron Gastroenterology Associates Center for Digestive Care

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan53 sites

  • Asahikawa Medical University Hospital

    Asahikawa, 078-8510

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, 807-8555

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Tokai University Hachioji Hospital

    Hachiōji, 192-0032

  • Hamamatsu University Hospital

    Hamamatsu, 431-3192

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, 036-8545

  • Hirosaki University Hospital

    Hirosaki, 036-8563

  • Hitachi General Hospital

    Hitachi, 317-0077

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima, 892-0843

  • Ofuna Chuo Hospital

    Kamakura, 247-0056

  • Kanazawa University Hospital

    Kanazawa, 9208641

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa, 277-0871

  • Saitama Medical University Saitama Medical Center

    Kawagoe, 350-8550

  • Kyushu Rosai Hospital

    Kitakyushu, 800-0296

  • Kobe University Hospital

    Kobe, 650-0017

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • Nagaoka Red Cross Hospital

    Nagaoka, 940-2085

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, 466 8560

  • Niigata University Medical And Dental Hospital

    Niigata, 951-8520

  • Okayama University Hospital

    Okayama, 700-8558

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Osaka City University Hospital

    Osaka, 545-8586

  • Japan Community Health Care Organization Osaka Hospital

    Osaka, 553-0003

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Saga University Hospital

    Saga, 849-0937

  • Tokitokai Tokito Clinic Coloproctology Center

    Saitama, 336-0963

  • 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, 060-8556

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • Tohoku University Hospital

    Sendai, 980-8574

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, 321-0293

  • Jichi Medical University Hospital

    Shimotsuke, 329-0498

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku Ku, 162 8655

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, 162-8666

  • Tokyo Metropolitan Bokutoh Hospital

    Sumida Ku, 130 8575

  • Takamatsu Red Cross Hospital

    Takamatsu, 760-0017

  • The Jikei University Hospital

    Tokyo, 105 8471

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642

  • Toyama Prefectural Central Hospital

    Toyama, 9308550

  • Ieda Hospital

    Toyota, 470-1219

  • Mie University Hospital

    Tsu, 514-8507

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Germany42 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte

    Berlin, 10117

  • Praxis Fur Gastroenteroligie

    Berlin, 10825

  • Charite Campus Benjamin Franklin

    Berlin, 12200

  • Krankenhaus Waldfriede Mitte

    Berlin, 14163

  • Evangelisches Krankenhaus Kalk

    Cologne, 51103

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221

  • University Hospital Dresden

    Dresden, 1307

  • MVZ Sanaklinikum Duisburg

    Duisburg, 47055

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Essen

    Essen, 45147

  • JWG-University Hospital

    Frankfurt, 60590

  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum Fulda - Tumorklinik - Germany

    Fulda, 36043

  • Curiositas ad Sanum Studien und Beratungs GmBH

    Haag, 83527

  • Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

    Halle, 06120

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 6108

  • CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20251

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

    Heidelberg, 69115

  • University Hospital Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Jena

    Jena, 07747

  • Praxisgemeinschaft Jerichow

    Jerichow, 39319

  • Gastroenterologische Spezialpraxis - Berlin-Karlshorst

    Karlshorst, 10318

  • Gastroenterologie Opernstrasse

    Kassel, 34117

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

  • Eugastro GmbH

    Leipzig, 04103

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339

  • Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Klinikum der Universitaet Muenchen

    Munich, 81377

  • Universitatsklinikum Munster

    Münster, 48149

  • MVZ Portal 10

    Münster, 48155

  • Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

    Nordhausen, 99734

  • Medius Klinik Nurtingen

    Nürtingen, 72622

  • Siloah St Trudpert Klinikum

    Pforzheim, 75179

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

  • Universitaetsmedizin Rostock

    Rostock, 18057

  • Zentrum für Gastroenterologie Saar MVZ GmbH

    Saarbrücken, 66111

  • Universitatsklinikum Tubingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89070

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

China24 sites

  • China Japan Friendship Hospital

    Beijing, 100029

  • The second Xiangya Hospital of Central South University

    Changsha, 200120

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213004

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing Medical University

    Chongqing, 400013

  • The First People's Hospital of Foshan

    Foshan, 528010

  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

    Guangzhou, 510000

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515

  • Hainan General Hospital

    Haikou, 570311

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Jinhua municipal central hospital

    Jinhua, 321000

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Zhongda Hospital Southeast University

    Nanjing, 210000

  • Nanjing Drum Tower Hospital

    Nanjing, 210008

  • Shanghai East Hospital

    Shanghai, 200120

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai

  • The Central Hospital of Wuhan

    Wuhan, 430014

  • Wuhan Union Hospital

    Wuhan, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • Wuxi People s Hospital

    Wuxi, 214023

  • Zhongshan Hospital, Xiamen University

    Xiamen, 361004

  • Yangzhou First People's Hospital

    Yangzhou, 225001

  • ZhuZhou Central Hospital

    Zhuzhou, 412007

Other trials in China

Brazil23 sites

  • Hospital Das Clinicas Da Ufmg

    Belo Horizonte - MG, 30130-100

  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

    Botucatu, 18608-025

  • Impar Servicos Hospitalares S/A - Hospital Brasilia

    Brasília, 71.681-603

  • Chronos Clinica Medica Ltda

    Brasília, 72145 450

  • Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

    Curitiba, 80430-180

  • Centro de Estudos Clínicos do Interior Paulista - CECIP

    Jaú, 17201-130

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020 090

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-003

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430-001

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14048-900

  • Universidade Federal do Rio de Janeiro - Faculdade de Medicina

    Rio de Janeiro, 21941-913

  • Pesquisare Saude

    Santo André, 09080-110

  • Irmandade da Santa Casa da Misericórdia de Santos

    Santos, 11075-101

  • Kaiser Hospta

    São José do Rio Preto, 15015-110

  • CPQuali Pesquisa Clinica LTDA ME

    São Paulo, 01228 000

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, 01228-200

  • Hospital Nove de Julho

    São Paulo, 01409 902

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

  • Instituto D Or de Pesquisa e Ensino IDOR

    São Paulo, 04502-001

  • Hepatogastro

    São Paulo, 04543-011

  • BR Trials

    São Paulo, 05003-090

Other trials in Brazil

Canada22 sites

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

  • Viable Clinical Research

    Bridgewater, B4V 3N2

  • Foothills Hospital

    Calgary, Alberta, T2N4N1

  • Viable Clinical Research 1

    Dartmouth, Nova Scotia, B2W 6L4

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2X8

  • Covenant Health/Grey Nuns hospital

    Edmonton, Alberta, T6K 4B2

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • McGill University - Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Fraser Clinical Trials Inc.

    New Westminster, British Columbia, V3L 3W4

  • Hopital Chicoutimi

    Saguenay, G7H3C3

  • St. Jerome Medical Research

    Saint-Jérôme, Quebec, J7Z 5T3

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

  • The Gordon & Leslie Diamond Health Care Center

    Vancouver, British Columbia, V5Z 1M9

  • GIRI Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • The Medical Arts Health Research Group

    Vancouver, British Columbia, V7M 2H4

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8P 2P5

  • CMIIM, Centre médical L'Enjeu

    Ville Mont-Royal, Quebec, H3P-3E5

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Poland21 sites

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Centrum Medyczne Plejady

    Krakow, 30 363

  • Centrum Medyczne Promed

    Krakow, 31-513

  • AmiCare Centrum Medyczne

    Lodz, 90-644

  • Gastromed ZOZ

    Lublin, 20-583

  • Wojewodzki Szpital Specjalistyczny w Olsztynie

    Olsztyn, 10 561

  • Synexus Polska Sp z o o

    Poznan, 61 441

  • Twoja Przychodnia

    Poznan, 61-293

  • Centrum Medyczne Medyk

    Rzeszów, 35-326

  • Endoskopia Sp z o.o.

    Sopot, 81-756

  • Sonomed Sp. z o.o.

    Szczecin, 71-685

  • GASTROMED Sp. z o.o.

    Torun, 87 100

  • Centrum Zdrowia Matki Dziecka i Mlodziezy

    Warsaw, 00 632

  • Centralny Szpital Kliniczny Mswia

    Warsaw, 02 507

  • Reumatika-Centrum Reumatologii, NZOZ

    Warsaw, 02-655

  • NZOZ Vivamed

    Warsaw, 03 580

  • Bodyclinic Sp. z o.o. sp. k

    Warsaw, 03 712

  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

    Włocławek, 87-800

  • Melita Medical Sp. z o.o.

    Wroclaw, 50 449

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

South Korea17 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Kosin University Gospel Hospital

    Busan, 48108

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Hospital

    Daegu, 42415

  • Dongguk University Ilsan Hospital

    Goyang-si, 10326

  • Chosun university hospital

    Gwangju, 61453

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • The Catholic University of Korea Seoul St.Mary's Hospital

    Seoul, 06591

  • Kyung Hee University Hospital

    Seoul, 130 050

  • The Catholic University of Korea Seoul St.Marys Hospital 1

    Seoul, 6591

  • The Catholic University of Korea

    Suwon, 16247

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

France15 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHRU De Besancon

    Besançon, 25030

  • Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

    Créteil, 94010

  • CHU Grenoble

    Grenoble, 38700

  • Hopital Nord Marseille

    Marseille, 13915

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

  • CHU de Nice Hopital de l Archet

    Nice, 06202

  • Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux

    Paris, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHRU Hopital de Pontchaillou

    Rennes, 35033

  • Hôpital Yves Le Foll

    Saint-Brieuc, 22027

  • Centre hospitalier universitaire de St Etienne

    Saint-Etienne, 42055

  • CHU Rangueil

    Toulouse, 31059

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

India12 sites

  • ICON Hospital Orchid Medi services and Research Private Limited

    Ahmedabad, 380009

  • M S Ramaiah Medical College and Hospital

    Bengaluru, 560054

  • Siksha O Anusandhan University - Institute of Medical Scienc

    Bhubaneswar, 751030

  • Srm Institutes For Medical Science (Sims)

    Chennai, 600026

  • Fortis Memorial Research Institute

    Gūrgaon, 122002

  • Asian Institute Of Gastroenterology

    Hyderabad, 500082

  • Yashoda Super Speciality Hospitals 1

    Hyderabad, 500082

  • P D Hinduja National Hospital and Medical Research Center

    Mumbai, 400016

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Yashoda Super Speciality Hospitals

    Secunderabad, 500003

  • Surat Institute of Digestive Sciences Hospitals

    Surat, 395002

  • Gujarat Gastro and Vascular Hospital

    Surat, 395009

Other trials in India

Italy12 sites

  • Università degli Studi di Bari

    Bari, 70124

  • A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

    Catania, 95126

  • AOU Policlinico G.Martino

    Messina, 98125

  • Ospedale San Raffaele

    Milan, 20132

  • Ospedale Specializzato in Gastroenterologia Saverio de Bellis

    Monopoli, 70043

  • Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

    Monserrato, 09042

  • Azienda Ospedaliera San Gerardo

    Monza, 20090

  • Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

    Negrar ( Ve), 37024

  • Ospedale Villa Sofia-Cervello

    Palermo, 90146

  • Catholic University of Sacred Hearth

    Roma, 00168

  • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

    Rozzano, 20089

  • Ospedale Molinette, AO Città della Salute e della Scienza di

    Torino, 10126

Other trials in Italy

Australia10 sites

  • The Queen Elizabeth Hospital

    Adelaide, 5011

  • Box Hill Hospital

    Box Hill, 3128

  • Monash Health, Monash Medical Centre

    Clayton, 3168

  • Western Health

    Footscray, 3011

  • St Vincent's hospital

    Melbourne, 3002

  • Royal Prince Alfred Hospital

    Newtown, 2042

  • Royal Adelaide Hospital

    North Terrace, 5000

  • Royal Melbourne Hospital

    Parkville, 3050

  • Nepean Hospital

    Penrith, 2747

  • Mater Hospital Brisbane Inflammatory Bowel Diseases

    South Brisbane, 4101

Other trials in Australia

Belgium10 sites

  • GZA Ziekenhuizen

    Antwerp, 2018

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHC MontLegia

    Liège, 4000

  • CHU de Liege

    Liège, 4000

  • Az Sint-Maarten

    Mechelen, 2800

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

  • Vitaz

    Sint-Niklaas

Other trials in Belgium

Israel10 sites

  • Haemek Medical Center - Afula

    Afula, 1834111

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Hebrew University Medical Center

    Jerusalem, 91120

  • Rabin Med Ctr Beilinson Hosp

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Tzrifin, 70300

Other trials in Israel

United Kingdom10 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Velocity Clinical Research

    High Wycombe, HP112QW

  • Whipps Cross University Hospital

    London, E111NR

  • St Georges Healthcare NHS Trust

    London, SW19 0QT

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Hungary6 sites

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest, 1082

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1088

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • Szegedi Tudomanyegyetem

    Szeged, H-6720

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, H-9700

Other trials in Hungary

Netherlands6 sites

  • Academisch Medisch Centrum Universiteit van Amsterdam

    Amsterdam, 1105 AZ

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Erasmus MC

    Rotterdam, 3015 GD

  • UMC Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

South Africa6 sites

  • Worthwhile Clinical Trials Lakeview Hospital

    Benoni, 1501

  • Mediclinic Panorama

    Cape Town, 7500

  • Inspired GI Care

    Cape Town, 7800

  • Clinical Research Centre University of Cape Town

    Cape Town, 7925

  • Groote Schur Hospital

    Cape Town, 7925

  • Hillcrest private

    Durban, 3610

Other trials in South Africa

Spain6 sites

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. de Navarra

    Pamplona, 31008

  • Hosp. Montecelo

    Pontevedra, 36071

  • Corporacio Sanitari Parc Tauli

    Sabadell, 8208

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Univ. de Torrejon

    Torrejón de Ardoz, 28850

Other trials in Spain

Denmark5 sites

  • Aarhus University Hospital

    Aarhus

  • Bispebjerg Og Frederiksberg Hospital

    Copenhagen, 2400

  • Herlev Hospital, University of Copenhagen

    Herlev, 2730

  • Odense Universitetshospital

    Odense, 5000

  • Silkeborg Hospital

    Silkeborg, 8600

Other trials in Denmark

Norway5 sites

  • Alesund sjukehus

    Ålesund, 6010

  • Vestre Viken HF Baerum Sykehus

    Gjettum, 1346

  • Akershus Universitetssykehus

    Lørenskog, 1478

  • Oslo University Hospital HF Ulleval sykehus

    Oslo, 0450

  • Universitetssykehuset Nord-Norge HF

    Tromsø, N-9038

Other trials in Norway

Switzerland5 sites

  • Universitatsspital Basel

    Basel, 4056

  • Inselspital Universitatsspital Bern

    Bern, 3010

  • Gastroenterologische Praxis Balsiger und Seibold

    Bern, 3012

  • Kantonsspital St Gallen

    Sankt Gallen, 9007

  • UniversitaetsSpital Zuerich

    Zurich, 8091

Other trials in Switzerland

Austria4 sites

  • Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III

    Salzburg, 5020

  • Akh Wien 1

    Vienna, 1090

  • Akh Wien

    Vienna, 1090

  • Klinikum Wels Grieskirchen

    Wels, 4600

Other trials in Austria

Jordan4 sites

  • Jordan University Hospital

    Amman, 11942

  • Abdali Hospital

    Amman

  • Irbid Specialty Hospital

    Irbid, 21110

  • King Abdullah University Hospital

    Irbid, 22110

Other trials in Jordan

Malaysia4 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 5460

  • Hospital Ampang

    Ampang, 68000

  • Hospital Pulau Pinang

    George Town, 10990

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

Other trials in Malaysia

Portugal4 sites

  • Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria

    Lisbon, 1649-035

  • Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

    Portimão, 8500-338

  • Centro Hospitalar Vila Nova de Gaia

    Porto, 4434-502

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Singapore4 sites

  • Singapore General Hospital

    Singapore, 169608

  • KL Ling Gastroenterology and Liver Clinic

    Singapore, 228510

  • Gi Associates Gastroenterology

    Singapore, 258499

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Taiwan4 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Croatia3 sites

  • Opca bolnica Bjelovar

    Bjelovar, 43000

  • University Hospital Center Split

    Split, 21000

  • University Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Czechia3 sites

  • Vojenska nemocnice Brno

    Brno, 636 00

  • ISCARE a.s.

    Prague, 170 04

  • Detska klinika Masarykovy nemocnice v Usti nad Labem

    Ústí nad Labem, 401 11

Other trials in Czechia

Estonia3 sites

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tallinn Children's Hospital

    Tallinn, 13419

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Greece3 sites

  • General Hospital of Athens 'Ippokrateion'

    Athens, 115 27

  • Sotiria General State Hospital of Chest Diseases

    Athens, 115 27

  • Hippokration Hospital

    Thessaloniki, 54642

Other trials in Greece

New Zealand3 sites

  • Dunedin Hospital

    Dunedin, 9016

  • Hutt Hospital

    Lower Hutt, 5010

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Sweden3 sites

  • Universitetssjukhuset Orebro

    Örebro, 70185

  • Karolinska University Hospital

    Solna, 17176

  • Ersta sjukhus

    Stockholm, 116 91

Other trials in Sweden

Bulgaria2 sites

  • UMHAT 'Aleksandrovska' EAD

    Sofia, 1431

  • MHAT Tzaritza Joanna

    Sofia, 1527

Other trials in Bulgaria

Slovenia2 sites

  • Splosna bolnisnica Celje

    Celje, 3000

  • Univerzitetni klinicni center Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: 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 Crohn's Disease

The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

Conditions
Crohn's Disease
Being tested
Guselkumab, Golimumab, JNJ-78934804, Placebo
Medical subject headings
Crohn Disease

What participants receive

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

  • GuselkumabBiological

    Guselkumab will be administered as subcutaneous injection.

  • GolimumabBiological

    Golimumab will be administered as subcutaneous injection.

  • JNJ-78934804Biological

    JNJ-78934804 will be administered subcutaneously as per defined regimen.

  • PlaceboDrug

    Placebo will be administered as subcutaneous injection.

Study groups in NCT05242471
Study groupRoleWhat they receive
Group 1: PlaceboPlacebo comparatorParticipants will receive placebo subcutaneously (SC). All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Drug: Placebo
Group 2: GuselkumabExperimentalParticipants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Biological: Guselkumab
Group 3: GolimumabExperimentalParticipants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Biological: Golimumab
Group 4: JNJ-78934804 (High-dose)ExperimentalParticipants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Biological: JNJ-78934804
Group 5: JNJ-78934804 (Mid-dose)ExperimentalParticipants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Biological: JNJ-78934804
Group 6: JNJ-78934804 (Low-dose)ExperimentalParticipants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension.
Receives: Biological: JNJ-78934804

What is being measured

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

  1. Percentage of Participants with Clinical Remission at Week 48

    Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).

    Measured: Week 48

  2. Percentage of Participants with Endoscopic Response at Week 48

    Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the simple endoscopic score for Crohn's disease (SES-CD), as assessed by central endoscopy reading.

    Measured: Week 48

Secondary outcomes (18)

  1. Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48

    Percentage of participants with PRO-2 remission at Week 48 will be reported. PRO-2 remission is based on the average daily abdominal pain (AP) and stool frequency (SF) scores.

    Measured: Week 48

  2. Percentage of Participants with Endoscopic Remission at Week 48

    Percentage of participants with endoscopic remission at Week 48 will be reported. Endoscopic remission is based on the SES-CD, as assessed by central endoscopy reading.

    Measured: Week 48

  3. Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48

    Percentage of participants with corticosteroid-free (60-day) clinical remission at Week 48 will be reported.

    Measured: Week 48

  4. Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48

    Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).

    Measured: Week 48

  5. Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48

    Percentage of participants with endoscopic response at Week 48 will be reported. Endoscopic response is based on change from baseline in the SES-CD, as assessed by central endoscopy reading.

    Measured: Week 48

  6. Percentage of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Measured: Up to Week 48

  7. Percentage of Participants with Serious Adverse Events (SAEs)

    A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

    Measured: Up to Week 48

  8. Clinical Laboratory Parameters Over Time

    Clinical laboratory parameters over time will be reported.

    Measured: Up to Week 48

  9. Vital Sign Parameters Over Time

    Vital sign parameters over time will be reported.

    Measured: Up to Week 48

  10. Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score

    The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Worsening of suicidal ideation is defined as an increase in severity of suicidal ideation from baseline.

    Measured: Up to Week 48

  11. Serum Concentrations of Guselkumab Over Time

    Serum concentrations of guselkumab over time will be reported. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive method.

    Measured: Up to Week 48

  12. Serum Concentrations of Golimumab Over Time

    Serum concentrations of golimumab over time will be reported. Serum samples will be analyzed to determine concentrations of golimumab using a validated, specific, and sensitive method.

    Measured: Up to Week 48

  13. Percentage of Participants with Antibodies to Guselkumab

    Percentage of participants with antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  14. Titers of Antibodies to Guselkumab

    Titers of antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  15. Percentage of Participants with Antibodies to Golimumab

    Percentage of participants with antibodies to golimumab will be reported.

    Measured: Up to Week 48

  16. Titers of Antibodies to Golimumab

    Titers of antibodies to golimumab will be reported.

    Measured: Up to Week 48

  17. Percentage of Participants with Neutralizing Antibodies to Guselkumab.

    Percentage of participants with neutralizing antibodies to guselkumab will be reported.

    Measured: Up to Week 48

  18. Percentage of Participants with Neutralizing Antibodies to Golimumab

    Percentage of participants with neutralizing antibodies to golimumab will be reported.

    Measured: Up to Week 48

Timeline

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

  1. First posted16 Feb 2022
  2. Study start22 Jul 2022
  3. Primary completion23 May 2025
  4. Study completion5 Nov 2029 (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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
703 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242471
Sponsor's protocol ID
CR109178
Other IDs
78934804CRD2001, 2021-003314-39, 2023-504741-32-00, 2023
Acronym
DUET-CD
Status last verified
Nov 2026
First submitted
15 Feb 2022
Last updated
4 Nov 2026
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guselkumab, Golimumab and JNJ-78934804 in people with Crohn's Disease, run by Janssen Research & Development, LLC at 456 sites in 36 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 2 inclusion and 0 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 456 sites in United States, Japan, Germany, China, Brazil and 31 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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Percentage of Participants with Clinical Remission at Week 48 (time frame: Week 48). The study lists 2 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 NCT05242471.

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 4 Nov 2026.

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