A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
DUET-UC
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 Ulcerative Colitis
4 other identifiers
interventional
577
34 countries
385
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2022
Longer than P75 for phase_2
385 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
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2029
ExpectedApril 13, 2026
April 1, 2026
2.7 years
February 15, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Clinical Remission at Week 48
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
Week 48
Secondary Outcomes (18)
Percentage of Participants with Endoscopic Improvement at Week 48
Week 48
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48
Week 48
Percentage of Participants with Symptomatic Remission at Week 48
Week 48
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48
Week 48
Secondary Comparison: Percentage of Participants with Clinical Remission 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:
- Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
- Moderately to severely active UC as assessed by the modified Mayo score
- Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
- If female and of childbearing potential, must meet the contraception and reproduction requirements
You may not qualify if:
- Has severe extensive colitis as defined in the protocol
- Extent of inflammatory disease limited to the rectum
- Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease (CD)
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
- Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (403)
Valley Gastroenterology Medical Group
Arcadia, California, 91006, United States
Southern California Research Center
Coronado, California, 92118, United States
Om Research LLC
Lancaster, California, 93534, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Medical Research Center of Connecticut
Hamden, Connecticut, 06518, United States
Yale University
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
Digestive and Liver Disease Institute
Kissimmee, Florida, 34741, United States
Osceola Regional Hospital
Kissimmee, Florida, 34741, United States
Florida Research Center Inc.
Lakewood Rch, Florida, 34211, United States
University of Miami
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
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Associates 1
Marietta, Georgia, 30060, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Gastroenterology Consultants
Roswell, Georgia, 30076, United States
Grand Teton Gastroenterology
Idaho Falls, Idaho, 83404, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology of Southern Indiana
New Albany, Indiana, 47150, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815-7313, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400, United States
Brigham And Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti, Michigan, 48197, 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
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 North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Tryon Medical Group
Charlotte, North Carolina, 28210, United States
Onsite Clinical Solutions
Charlotte, North Carolina, 28277, United States
Care Access Research, Kinston
Kinston, North Carolina, 28501, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060, United States
Frontier Clinical Research
Uniontown, Pennsylvania, 15401, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Digestive Disease Associates
Rock Hill, South Carolina, 29732, United States
Gastro One
Germantown, Tennessee, 38138, United States
Etsu Quillen College Of Medicine
Johnson City, Tennessee, 37604, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37067, United States
UT Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
GI Specialists of Houston
Houston, Texas, 77346, United States
Gastroenterology Clinic Of San Antonio P A
San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants
Southlake, Texas, 76092, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Medical College Of Virginia Hospital
Richmond, Virginia, 23249, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Virginia Mason Medical Center
Seattle, Washington, 98111, United States
Digestive Health Specialists
Tacoma, Washington, 98405, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
CIPREC
Buenos Aires, C1119ACN, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo
Ciudad Autonoma Buenos Aires, C1264AAN, Argentina
Sanatorio Duarte Quiroz
Córdoba, X5002AOQ, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, B7600FYK, Argentina
Hospital Provincial del Centenario
Rosario, 2002, Argentina
Box Hill Hospital
Box Hill, 3128, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
Monash Health, Monash Medical Centre
Clayton, 3168, Australia
Concord Hospital
Concord, 2139, Australia
Western Health
Footscray, 3011, Australia
Coastal Digestive Health
Maroochydore, 4558, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Royal Adelaide Hospital
North Terrace, 5000, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
The Alfred Hospital
Prahran, 3004, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, 1020, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Klinikum Wels Grieskirchen
Wels, 4600, Austria
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, 8000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHC MontLegia
Liège, 4000, Belgium
CHU de Liege
Liège, 4000, Belgium
Vitaz
Sint-Niklaas, Belgium
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, 18618-970, Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, 70200-730, Brazil
Chronos Clinica Medica LTDA Chronos Pesquisa Clinica
Brasília, 72145-450, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, 95070-560, Brazil
Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica
Curitiba, 80430-180, Brazil
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035-003, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Universidade Federal do Rio de Janeiro - Faculdade de Medicina
Rio de Janeiro, 21941-913, Brazil
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, 40150 150, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-101, Brazil
Hospital Nove de Julho
São Paulo, 01409 902, Brazil
BR Trials
São Paulo, 03325-050, 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
Medical Centre Hipocrat
Haskovo, 6300, Bulgaria
Diagnostic Consulting Center I Sliven
Sliven, 8800, Bulgaria
UMHAT 'Tsaritsa Yoanna'
Sofia, 1527, Bulgaria
University Hospital Alexandrovska - Clinic of Nephrology
Sofia-Grad, 1431, Bulgaria
Medical Center -Medika Plus
Veliko Tarnovo, 5000, Bulgaria
Multriprofile Hospital for Active Treatment Hristo Botev
Vratsa, 3000, Bulgaria
Foothills Hospital
Calgary, Alberta, T2N 2T9, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, T5R 1W2, Canada
Covenant Health/Grey Nuns hospital
Edmonton, Alberta, T6L 6K3, Canada
Columbia Gastroenterology
New Westminster, British Columbia, 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
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
London Health Sciences Centre - University Campus
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
CMIIM, Centre médical L'Enjeu
Mount Royal, Quebec, H3P 3E5, Canada
St. Jerome Medical Research
Saint-Jérôme, Quebec, V8R 4R2, Canada
Viable Clinical Research
Bridgewater, B4V 3N2, Canada
Hopital Chicoutimi
Saguenay, G7H3C3, Canada
Hospital Clinico Regional Dr. Guillermo Grant Benavente
Concepción, 4030000, Chile
Clinica Dermacross S A
Santiago, 7640881, Chile
Complejo Asistencial Hospital Dr. Sótero del Río
Santiago, 8207257, Chile
Centro de Estudios Clínicos e Investigación Médica (CeCim)
Santiago, 8331143, Chile
China Japan Friendship Hospital
Chaoyang, 100013, China
West China Hospital Sichuan University
Chengdu, 610041, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310016, China
Jinhua municipal central hospital
Jinhua, 321000, China
Zhongda Hospital Southeast University
Nanjing, 210009, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022, 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
Aalborg Hospital
Aalborg, 9000, Denmark
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
East Tallinn Central Hospital
Tallinn, 10138, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
CHU Amiens - Hopital Sud
Amiens, 80054, France
Hopital Louis Mourier
Colombes, 92701, France
Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor
Créteil, 94010, France
CHU Grenoble
Grenoble, 38700, France
Centre Hospitalier Départemental VENDEE
La Roche-sur-Yon, 85925, France
CHRU de Lille Hopital Claude Huriez
Lille, 59037, France
Hopital Nord Marseille
Marseille, 13915, France
Hopital Saint Eloi
Montpellier, 34295, France
Clinique Ambroise Pare
Neuilly-sur-Seine, 92200, France
CHU de Nice Hopital de l Archet
Nice, 06202, France
CHU Nimes Hopital Caremeau
Nîmes, 30029, France
Hopital Haut-Leveque, CMC Magellan
Pessac, 33604, France
Hospices Civils de Lyon HCL
Pierre-Bénite, 69495, France
CHU Saint Etienne
Saint-Etienne, 42270, France
Hopital de 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 - Universitaetsmedizin Berlin (CCM)
Berlin, 12203, Germany
Krankenhaus Waldfriede Mitte
Berlin, 14163, Germany
University Hospital Dresden
Dresden, 1307, Germany
Universitaetsklinik Erlangen
Erlangen, 91054, Germany
JWG-University Hospital
Frankfurt, 69590, 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
Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk
Halle, 06097, Germany
BSF Studiengesellschaft
Halle, 06108, 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
Eugastro GmbH
Leipzig, 04103, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423, Germany
Klinikum der Universitaet Muenchen
Munich, 81377, Germany
Praxis fur Innere Medizin und Gastroenterologie
Münster, 48149, Germany
MVZ Portal 10
Münster, 48155, Germany
Medius Klinik Nurtingen
Nürtingen, 72622, Germany
Siloah St Trudpert Klinikum
Pforzheim, 75179, Germany
Zentrum für Gastroenterologie Saar MVZ GmbH
Saarbrücken, 66111, Germany
Universitaetsklinik Tuebingen
Tübingen, 72076, Germany
Universitatsklinikum Ulm
Ulm, 89070, Germany
Gemeinschaftspraxis Jakobeit
Wipperfürth, 51688, Germany
Universitatsklinikum Wurzburg
Würzburg, 97080, Germany
Sotiria General State Hospital of Chest Diseases
Athens, 115 27, Greece
Alexandra General Hospital of Athens
Athens, 11528, Greece
Nikaia General Hospital
Piraeus, 184 54, Greece
Hippokration Hospital
Thessaloniki, 54642, Greece
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1062, Hungary
Semmelweis Egyetem
Budapest, H-1088, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136, Hungary
Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Szegedi Tud Egyetem Szent Gyorgyi Albert Klin Kozp
Szeged, 6720, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, H-9700, Hungary
M S Ramaiah Medical College and Hospital
Bangalore, 560054, India
Siksha O Anusandhan University - Institute of Medical Scienc
Bhubaneswar, 751003, India
Apex Hospitals Ltd
Jaipur, 302017, India
G.B. Pant Hospital
New Delhi, 110 002, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Fortis Hospital
New Delhi, 110088, India
Yashoda Super Speciality Hospitals
Secunderabad, 500003, India
Surat Institute of Digestive Sciences Hospitals
Surat, 395002, India
Haemek Medical Center - Afula
Afula, 1834111, Israel
Rambam Medical Center
Haifa, 31096, Israel
Bnai Zion Medical Center
Haifa, 3339419, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah Hebrew University Medical Center
Jerusalem, 91120, Israel
Rabin Medical Center Beilinson Campus
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 HSR Istituto Scientifico Universitario San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato
Monserrato, 09042, Italy
Azienda Ospedaliera San Gerardo
Monza, 20090, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, 37024, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Università Campus Biomedico di Roma
Roma, 00128, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
Rozzano, 20089, Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, 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
Kitakyushu Municipal Medical Center
Fukuoka-ken, 802-0077, Japan
Gifu Prefectural General Medical Center
Gifu, 500-8717, 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
Tokai University Hospital
Isehara, 259-1193, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Ofuna Chuo Hospital
Kamakura, 247-0056, Japan
Matsushima Clinic
Kanagawa, 220-0045, Japan
Nara Medical University Hospital
Kashihara, 634-8522, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-0027, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Kyoto University Hospital
Kyoto, 606 8507, Japan
Gunma University Hospital
Maebashi, 371-8511, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Iwate Medical University Hospital
Morioka, 112-0015, Japan
Nagoya University Hospital
Nagoya, 466 8560, Japan
Nagoya City University Hospital
Nagoya, 467-8602, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, 663-8501, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka City University Hospital
Osaka, 545-8586, Japan
Japan Community Health Care Organization Osaka Hospital
Osaka, 553-0003, Japan
Ogaki Municipal Hospital
Ōgaki, 503-8502, Japan
Oita Red Cross Hospital
Ōita, 870-0033, 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 Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Sapporo IBD Clinic
Sapporo Chuo-ku, 064-0919, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
The Jikei University Hospital
Tokyo, 105 8471, Japan
Tokyo Saiseikai Central Hospital
Tokyo, 108-0073, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, 152 8902, Japan
Tokyo Medical University Hospital
Tokyo, 160-0023, Japan
Oji General Hospital
Tomakomai, 053-8506, Japan
Toyama Prefectural Central Hospital
Toyama, 930 8550, Japan
Toyota Kosei Hospital
Toyota, 470-0396, Japan
Mie University Hospital
Tsu, 514-8507, Japan
University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
Wakayama Medical University Hospital
Wakayama, 641 8510, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Istishari Hospital
Amman, 11184, Jordan
Jordan University Hospital
Amman, 11942, Jordan
Irbid Specialty Hospital
Irbid, 21110, Jordan
King Abdullah University Hospital
Irbid, 22110, Jordan
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 105 AZ, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Maastricht University Medical Centre
Maastricht, 6229 HX, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Christchurch Hospital
Christchurch, 8140, New Zealand
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
Sykehuset Innlandet HF Gjøvik
Gjøvik, 2819, 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 No2
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
ETG Lublin
Lublin, 20-412, Poland
Gastromed Spotka Z Ograniczona Odpowiedzialnoscia Sp. K.
Lublin, 20-582, Poland
Allmedica
Nowy Targ, 34 400, 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
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, 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, 52 415, Poland
Przychodnia Vistamed
Wroclaw, 53 149, Poland
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, 54 144, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, 87-800, Poland
ETG Zamosc
Zamość, 22-400, Poland
Centro Hospitalar de Lisboa Norte Hospital Santa Maria
Lisbon, 1649-035, Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514, Portugal
Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio
Portimão, 8500-338, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E
Santa Maria da Feira, 4520-211, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502, Portugal
FNsP F.D.R. Banska Bystrica
Banská Bystrica, 974 01, Slovakia
Cliniq s.r.o.
Bratislava, 811 09, Slovakia
GASTRO I. s.r.o.
Prešov, 080 01, Slovakia
Gastroenterology Department ENDOMED, s.r.o.
Vranov nad Topľou, 093 01, Slovakia
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
Groote Schur Hospital
Cape Town, 7925, South Africa
Practice Dr Naeem Moosa
Johannesburg, 1827, South Africa
Emmed Research
Pretoria, 0002, South Africa
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Chosun university hospital
Gwangju, 61453, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450, 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
Ajou University Hospital
Suwon, 16499, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
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
Hosp. Alvaro Cunqueiro
Vigo, 36213, Spain
Karolinska Universitetssjukhuset Solna
Solna, 171 76, Sweden
Ersta sjukhus
Stockholm, 116 91, Sweden
Universitatsspital Basel
Basel, 4031, 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
Changhua Christian Hospital
Changhua, 500, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 407204, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital, Division of Infectious Diseases
Taipei, 100, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, 33305, Taiwan
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Velocity Clinical Research
High Wycombe, HP112QW, United Kingdom
Chelsea And Westminster Hospital
London, SW109NH, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, SW17 0QT, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, 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
September 19, 2022
Primary Completion
May 15, 2025
Study Completion (Estimated)
March 27, 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