A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
DUET-CD
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
4 other identifiers
interventional
703
34 countries
449
Brief Summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Longer than P75 for phase_2
449 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2029
ExpectedApril 13, 2026
April 1, 2026
2.8 years
February 15, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
Week 48
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.
Week 48
Secondary Outcomes (18)
Percentage of Participants with Patient-reported Outcomes (PRO)-2 Remission at Week 48
Week 48
Percentage of Participants with Endoscopic Remission at Week 48
Week 48
Percentage of Participants with Corticosteroid-Free Clinical Remission at Week 48
Week 48
Secondary Comparison: Percentage of Participants with Clinical Remission at Week 48
Week 48
Secondary Comparison: Percentage of Participants with Endoscopic Response at Week 48
Week 48
- +13 more secondary outcomes
Study Arms (6)
Group 1: Placebo
PLACEBO 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.
Group 2: Guselkumab
EXPERIMENTALParticipants 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.
Group 3: Golimumab
EXPERIMENTALParticipants 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.
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.
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.
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.
Interventions
JNJ-78934804 will be administered subcutaneously as per defined regimen.
Eligibility Criteria
You may qualify if:
- 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'
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (456)
University of Alabama Liver Center
Birmingham, Alabama, 35233, United States
Del Sol Research Management, LLC
Tucson, Arizona, 85715, United States
Moore Clinical Trials, LLC
Little Rock, Arkansas, 72205, United States
Om Research LLC
Apple Valley, California, 92307, United States
Valley Gastroenterology Medical Group
Arcadia, California, 91006, United States
Southern California Research Center
Coronado, California, 92118, United States
Desert Gastroenterology Associates
Lancaster, California, 93534, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA
Los Angeles, California, 90095, United States
Hoag Memorial Hospital
Newport Beach, California, 92658, United States
UCI Irvine Medical Center
Orange, California, 92868, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Pioneer Research Solutions Inc.
Coconut Creek, Florida, 33066, United States
Homestead Associates in Research Inc
Homestead, Florida, 33032, United States
Osceola Mental Health D/B/A Park Place Behavioral Health Care
Kissimmee, Florida, 34741, United States
Florida Research Center Inc.
Lakewood Rch, Florida, 34211, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Gastroenterology Group Of Naples
Naples, Florida, 34102, United States
Omega Research Consultants
Orlando, Florida, 32808, United States
Synergy Clinical Research
St. Petersburg, Florida, 33705, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Mississippi Medical Center
Atlanta, Georgia, 30342, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, 47150, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
Ascension via Christi Research
Wichita, Kansas, 67208, United States
Univ. of KS School of Med
Wichita, Kansas, 67214-3124, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, 70503, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Lahey Hospital & Medical Center
Boston, Massachusetts, 02215-5400, United States
Brigham And Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
FC Research, LLC
South Dartmouth, Massachusetts, 02747, United States
Detroit Clinical Research Center
Livonia, Michigan, 48152, United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan, 48197, United States
Gastrointestinal Associates LLP
Flowood, Mississippi, 39232, United States
Washington University
St Louis, Missouri, 63110, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Care Access Las Vegas
Las Vegas, Nevada, 89148, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, 03756, United States
Northwell Health
Great Neck, New York, 11021, United States
A1 Clinical Research
Jackson Heights, New York, 11372, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Lenox Hill Hospital
New York, New York, 10075, United States
Mohawk Valley Endoscopy Center
Utica, New York, 13502-6313, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7080, United States
Tryon Medical Group
Charlotte, North Carolina, 28210, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195-6501, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145, United States
The Oregon Clinic
Portland, Oregon, 97220-9428, United States
Susquehanna Gastroenterology Associates
Harrisburg, Pennsylvania, 17110-3673, United States
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Frontier Clinical Research
Smithfield, Pennsylvania, 15478, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Digestive Disease Associates
Rock Hill, South Carolina, 29732, United States
Saint Francis Hospital
Germantown, Tennessee, 38138, United States
Galen Medical Group
Hixson, Tennessee, 37343, United States
Etsu Quillen College Of Medicine
Johnson City, Tennessee, 37604, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37067, United States
Amel Med LLC Research
Austin, Texas, 78750, United States
Baylor University Medical Center
Dallas, Texas, 75242, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
Accurate Clinical Research
Houston, Texas, 77034, United States
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Digestive Health Specialists
Tyler, Texas, 75701, United States
Care Access Research, Ogden
Ogden, Utah, 84403, United States
Care Access Research- Salt Lake City
Salt Lake City, Utah, 84124, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Hunter Holmes McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
University of Washington Digestive Disease Center
Seattle, Washington, 98195, United States
Digestive Health Specialists 1
Tacoma, Washington, 98405, United States
Marshall Health Clinical Research Center
Huntington, West Virginia, 25701, United States
The Queen Elizabeth Hospital
Adelaide, 5011, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Monash Health, Monash Medical Centre
Clayton, 3168, Australia
Western Health
Footscray, 3011, Australia
St Vincent's hospital
Melbourne, 3002, Australia
Royal Prince Alfred Hospital
Newtown, 2042, Australia
Royal Adelaide Hospital
North Terrace, 5000, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Nepean Hospital
Penrith, 2747, Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, 4101, Australia
Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III
Salzburg, 5020, Austria
Akh Wien 1
Vienna, 1090, Austria
Akh Wien
Vienna, 1090, Austria
Klinikum Wels Grieskirchen
Wels, 4600, Austria
GZA Ziekenhuizen
Antwerp, 2018, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHC MontLegia
Liège, 4000, Belgium
CHU de Liege
Liège, 4000, Belgium
Az Sint-Maarten
Mechelen, 2800, Belgium
Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
Vitaz
Sint-Niklaas, Belgium
Hospital Das Clinicas Da Ufmg
Belo Horizonte - MG, 30130-100, Brazil
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu, 18608-025, Brazil
Impar Servicos Hospitalares S/A - Hospital Brasilia
Brasília, 71.681-603, Brazil
Chronos Clinica Medica Ltda
Brasília, 72145 450, Brazil
Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
Curitiba, 80430-180, Brazil
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú, 17201-130, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020 090, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, 90430-001, Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14048-900, Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, 21941-913, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-101, Brazil
Kaiser Hospta
São José do Rio Preto, 15015-110, Brazil
CPQuali Pesquisa Clinica LTDA ME
São Paulo, 01228 000, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, 01228-200, Brazil
Hospital Nove de Julho
São Paulo, 01409 902, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
São Paulo, 04039-004, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 04502-001, Brazil
Hepatogastro
São Paulo, 04543-011, Brazil
BR Trials
São Paulo, 05003-090, Brazil
UMHAT 'Aleksandrovska' EAD
Sofia, 1431, Bulgaria
MHAT Tzaritza Joanna
Sofia, 1527, Bulgaria
Foothills Hospital
Calgary, Alberta, T2N4N1, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8, Canada
Covenant Health/Grey Nuns hospital
Edmonton, Alberta, T6K 4B2, Canada
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4, Canada
The Gordon & Leslie Diamond Health Care Center
Vancouver, British Columbia, V5Z 1M9, Canada
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
The Medical Arts Health Research Group
Vancouver, British Columbia, V7M 2H4, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8P 2P5, Canada
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Viable Clinical Research 1
Dartmouth, Nova Scotia, B2W 6L4, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
McGill University - Health Centre - Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
St. Jerome Medical Research
Saint-Jérôme, Quebec, J7Z 5T3, Canada
CMIIM, Centre médical L'Enjeu
Ville Mont-Royal, Quebec, H3P-3E5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Viable Clinical Research
Bridgewater, B4V 3N2, Canada
Hopital Chicoutimi
Saguenay, G7H3C3, Canada
China Japan Friendship Hospital
Beijing, 100029, China
The second Xiangya Hospital of Central South University
Changsha, 200120, China
Changzhou No 2 Peoples Hospital
Changzhou, 213004, China
West China Hospital Sichuan University
Chengdu, 610041, China
Chongqing Medical University
Chongqing, 400013, China
The First People's Hospital of Foshan
Foshan, 528010, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital
Guangzhou, 510000, China
Guangzhou First Municipal People's Hospital
Guangzhou, 510180, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515, China
Hainan General Hospital
Haikou, 570311, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Jinhua municipal central hospital
Jinhua, 321000, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Zhongda Hospital Southeast University
Nanjing, 210000, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Shanghai East Hospital
Shanghai, 200120, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Wuhan Union Hospital
Wuhan, 430022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Wuxi People s Hospital
Wuxi, 214023, China
Zhongshan Hospital, Xiamen University
Xiamen, 361004, China
Yangzhou First People's Hospital
Yangzhou, 225001, China
ZhuZhou Central Hospital
Zhuzhou, 412007, China
Opca bolnica Bjelovar
Bjelovar, 43000, Croatia
University Hospital Center Split
Split, 21000, Croatia
University Hospital Dubrava
Zagreb, 10000, Croatia
Vojenska nemocnice Brno
Brno, 636 00, Czechia
ISCARE a.s.
Prague, 190 00, Czechia
Detska klinika Masarykovy nemocnice v Usti nad Labem
Ústí nad Labem, 401 11, Czechia
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg Og Frederiksberg Hospital
Copenhagen, 2400, Denmark
Herlev Hospital, University of Copenhagen
Herlev, 2730, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Silkeborg Hospital
Silkeborg, 8600, Denmark
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tallinn Children's Hospital
Tallinn, 13419, Estonia
Tartu University Hospital
Tartu, 50406, Estonia
CHU Amiens - Hopital Sud
Amiens, 80054, France
CHRU De Besancon
Besançon, 25030, France
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
Créteil, 94010, France
CHU Grenoble
Grenoble, 38700, France
Hopital Nord Marseille
Marseille, 13915, France
CHU de Nantes hotel Dieu
Nantes, 44093, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
CHU de Nice Hopital de l Archet
Nice, 06202, France
Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux
Paris, 75010, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHRU Hopital de Pontchaillou
Rennes, 35033, France
Hôpital Yves Le Foll
Saint-Brieuc, 22027, France
Centre hospitalier universitaire de St Etienne
Saint-Etienne, 42055, France
CHU Rangueil
Toulouse, 31059, France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117, Germany
Praxis Fur Gastroenteroligie
Berlin, 10825, Germany
Charite Campus Benjamin Franklin
Berlin, 12200, Germany
Krankenhaus Waldfriede Mitte
Berlin, 14163, Germany
Evangelisches Krankenhaus Kalk
Cologne, 51103, Germany
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, 85221, Germany
University Hospital Dresden
Dresden, 1307, Germany
MVZ Sanaklinikum Duisburg
Duisburg, 47055, Germany
Universitaetsklinik Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
JWG-University Hospital
Frankfurt, 60590, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Klinikum Fulda - Tumorklinik - Germany
Fulda, 36043, Germany
Curiositas ad Sanum Studien und Beratungs GmBH
Haag, 83527, Germany
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
Halle, 06120, Germany
BSF Studiengesellschaft
Halle, 6108, Germany
CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20251, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd
Heidelberg, 69115, Germany
University Hospital Heidelberg
Heidelberg, 69120, Germany
Universitatsklinikum Jena
Jena, 07747, Germany
Praxisgemeinschaft Jerichow
Jerichow, 39319, Germany
Gastroenterologische Spezialpraxis - Berlin-Karlshorst
Karlshorst, 10318, Germany
Gastroenterologie Opernstrasse
Kassel, 34117, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Medizinische Fakultät Mannheim der Universität Heidelberg
Mannheim, 68167, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Klinikum der Universitaet Muenchen
Munich, 81377, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
MVZ Portal 10
Münster, 48155, Germany
Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
Nordhausen, 99734, Germany
Medius Klinik Nurtingen
Nürtingen, 72622, Germany
Siloah St Trudpert Klinikum
Pforzheim, 75179, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Universitatsklinikum Ulm
Ulm, 89070, Germany
Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
General Hospital of Athens 'Ippokrateion'
Athens, 115 27, Greece
Sotiria General State Hospital of Chest Diseases
Athens, 115 27, Greece
Hippokration Hospital
Thessaloniki, 54642, Greece
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest, 1088, Hungary
Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Szegedi Tudomanyegyetem
Szeged, H-6720, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, H-9700, Hungary
ICON Hospital Orchid Medi services and Research Private Limited
Ahmedabad, 380009, India
M S Ramaiah Medical College and Hospital
Bengaluru, 560054, India
Siksha O Anusandhan University - Institute of Medical Scienc
Bhubaneswar, 751030, India
Srm Institutes For Medical Science (Sims)
Chennai, 600026, India
Fortis Memorial Research Institute
Gurugram, 122002, India
Asian Institute Of Gastroenterology
Hyderabad, 500082, India
Yashoda Super Speciality Hospitals 1
Hyderabad, 500082, India
P D Hinduja National Hospital and Medical Research Center
Mumbai, 400016, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Yashoda Super Speciality Hospitals
Secunderabad, 500003, India
Surat Institute of Digestive Sciences Hospitals
Surat, 395002, India
Gujarat Gastro and Vascular Hospital
Surat, 395009, India
Haemek Medical Center - Afula
Afula, 1834111, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Hebrew University Medical Center
Jerusalem, 91120, Israel
Rabin Med Ctr Beilinson Hosp
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Assaf Harofeh Medical Center
Tzrifin, 70300, Israel
Università degli Studi di Bari
Bari, 70124, Italy
A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale
Catania, 95126, Italy
AOU Policlinico G.Martino
Messina, 98125, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Ospedale Specializzato in Gastroenterologia Saverio de Bellis
Monopoli, 70043, Italy
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
Monserrato, 09042, Italy
Azienda Ospedaliera San Gerardo
Monza, 20090, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar ( Ve), 37024, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Catholic University of Sacred Hearth
Roma, 00168, Italy
IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
Rozzano, 20089, Italy
Ospedale Molinette, AO Città della Salute e della Scienza di
Torino, 10126, Italy
Asahikawa Medical University Hospital
Asahikawa, 078-8510, Japan
Tokyo Medical and Dental University Hospital
Bunkyō City, 113 8519, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, 807-8555, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Tokai University Hachioji Hospital
Hachiōji, 192-0032, Japan
Hamamatsu University Hospital
Hamamatsu, 431-3192, Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, 036-8545, Japan
Hirosaki University Hospital
Hirosaki, 036-8563, Japan
Hitachi General Hospital
Hitachi, 317-0077, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Ofuna Chuo Hospital
Kamakura, 247-0056, Japan
Kanazawa University Hospital
Kanazawa, 9208641, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Saitama Medical University Saitama Medical Center
Kawagoe, 350-8550, Japan
Kyushu Rosai Hospital
Kitakyushu, 800-0296, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Iwate Medical University Hospital
Morioka, 020-8505, Japan
Nagaoka Red Cross Hospital
Nagaoka, 940-2085, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Nagoya University Hospital
Nagoya, 466 8560, Japan
Niigata University Medical And Dental Hospital
Niigata, 951-8520, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Japan Community Health Care Organization Osaka Hospital
Osaka, 553-0003, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
Saga University Hospital
Saga, 849-0937, Japan
Tokitokai Tokito Clinic Coloproctology Center
Saitama, 336-0963, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Tokushukai Hospital
Sapporo, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
Sapporo Medical University Hospital
Sapporo, 060-8556, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Tohoku University Hospital
Sendai, 980-8574, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293, Japan
Jichi Medical University Hospital
Shimotsuke, 329-0498, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku Ku, 162 8655, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, 162-8666, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
Takamatsu Red Cross Hospital
Takamatsu, 760-0017, Japan
The Jikei University Hospital
Tokyo, 105 8471, Japan
Kitasato University Kitasato Institute Hospital
Tokyo, 108-8642, Japan
Toyama Prefectural Central Hospital
Toyama, 9308550, Japan
Ieda Hospital
Toyota, 470-1219, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Jordan University Hospital
Amman, 11942, Jordan
Abdali Hospital
Amman, Jordan
Irbid Specialty Hospital
Irbid, 21110, Jordan
King Abdullah University Hospital
Irbid, 22110, Jordan
Hospital Sultanah Bahiyah
Alor Star, 5460, Malaysia
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Pulau Pinang
George Town, 10990, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
UMC Utrecht
Utrecht, 3508 GA, Netherlands
Dunedin Hospital
Dunedin, 9016, New Zealand
Hutt Hospital
Lower Hutt, 5010, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Alesund sjukehus
Ålesund, 6010, Norway
Vestre Viken HF Baerum Sykehus
Gjettum, 1346, Norway
Akershus Universitetssykehus
Lørenskog, 1478, Norway
Oslo University Hospital HF Ulleval sykehus
Oslo, 0450, Norway
Universitetssykehuset Nord-Norge HF
Tromsø, N-9038, Norway
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
AmiCare Centrum Medyczne
Lodz, 90-644, Poland
Gastromed ZOZ
Lublin, 20-583, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10 561, Poland
Synexus Polska Sp z o o
Poznan, 61 441, Poland
Twoja Przychodnia
Poznan, 61-293, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, Poland
Endoskopia Sp z o.o.
Sopot, 81-756, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
GASTROMED Sp. z o.o.
Torun, 87 100, Poland
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warsaw, 00 632, Poland
Centralny Szpital Kliniczny Mswia
Warsaw, 02 507, Poland
Reumatika-Centrum Reumatologii, NZOZ
Warsaw, 02-655, Poland
NZOZ Vivamed
Warsaw, 03 580, Poland
Bodyclinic Sp. z o.o. sp. k
Warsaw, 03 712, Poland
Melita Medical Sp. z o.o.
Wroclaw, 50 449, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, 87-800, Poland
ETG Zamosc
Zamość, 22-400, Poland
Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
Lisbon, 1649-035, Portugal
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, 8500-338, Portugal
Centro Hospitalar Vila Nova de Gaia
Porto, 4434-502, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E
Santa Maria da Feira, 4520-211, Portugal
Singapore General Hospital
Singapore, 169608, Singapore
KL Ling Gastroenterology and Liver Clinic
Singapore, 228510, Singapore
Gi Associates Gastroenterology
Singapore, 258499, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Splosna bolnisnica Celje
Celje, 3000, Slovenia
Univerzitetni klinicni center Ljubljana
Ljubljana, 1000, Slovenia
Worthwhile Clinical Trials Lakeview Hospital
Benoni, 1501, South Africa
Mediclinic Panorama
Cape Town, 7500, South Africa
Inspired GI Care
Cape Town, 7800, South Africa
Clinical Research Centre University of Cape Town
Cape Town, 7925, South Africa
Groote Schur Hospital
Cape Town, 7925, South Africa
Hillcrest private
Durban, 3610, South Africa
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kosin University Gospel Hospital
Busan, 48108, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Dongguk University Ilsan Hospital
Goyang-si, 10326, South Korea
Chosun university hospital
Gwangju, 61453, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591, South Korea
Kyung Hee University Hospital
Seoul, 130 050, South Korea
The Catholic University of Korea Seoul St.Marys Hospital 1
Seoul, 6591, South Korea
The Catholic University of Korea
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. de Navarra
Pamplona, 31008, Spain
Hosp. Montecelo
Pontevedra, 36071, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 8208, Spain
Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
Hosp. Univ. de Torrejon
Torrejón de Ardoz, 28850, Spain
Universitetssjukhuset Orebro
Örebro, 70185, Sweden
Karolinska University Hospital
Solna, 17176, Sweden
Ersta sjukhus
Stockholm, 116 91, Sweden
Universitatsspital Basel
Basel, 4056, Switzerland
Inselspital Universitatsspital Bern
Bern, 3010, Switzerland
Gastroenterologische Praxis Balsiger und Seibold
Bern, 3012, Switzerland
Kantonsspital St Gallen
Sankt Gallen, 9007, Switzerland
UniversitaetsSpital Zuerich
Zurich, 8091, Switzerland
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Velocity Clinical Research
High Wycombe, HP112QW, United Kingdom
Whipps Cross University Hospital
London, E111NR, United Kingdom
St Georges Healthcare NHS Trust
London, SW19 0QT, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
February 16, 2022
Study Start
July 22, 2022
Primary Completion
May 23, 2025
Study Completion (Estimated)
November 5, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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