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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Official title: 78934804UCO3001: A Phase 3 Randomized, Double-blind, and Active Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
644
Start Date
2026-05-23
Completion Date
2030-10-16
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Guselkumab
Guselkumab will be administered subcutaneously.
Locations (318)
Mayo Clinic
Scottsdale, Arizona, United States
GIA Sun City
Sun City, Arizona, United States
Clinnova Research
Anaheim, California, United States
Gastro SB Clinic
Chula Vista, California, United States
United Medical Doctors
Los Alamitos, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Florida Research Center Inc.
Lakewood Rch, Florida, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
Endoscopic Research Inc
Orlando, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Specialists
Suwanee, Georgia, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
GIA Metairie
Metairie, Louisiana, United States
GIA Kansas City
Lee's Summit, Missouri, United States
New York Gastroenterology Associates
New York, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
Michigan Center of Medical Research
Farmington Hill, Pennsylvania, United States
Frontier Clinical Research
Uniontown, Pennsylvania, United States
Palmetto Primary and Specialty Care Physicians, Charleston
Summerville, South Carolina, United States
Gastro One
Cordova, Tennessee, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
GIA Webster
Webster, Texas, United States
GIA Richmond
Richmond, Virginia, United States
GI Alliance Tacoma
Tacoma, Washington, United States
Instituto Medico De Alta Complejidad (IMAC)
Buenos Aires, Argentina
GEDYT
Famailla, Argentina
Globalpsy
La Plata, Argentina
HIGEA
Mendoza, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina
Hospital Provincial del Centenario
Rosario, Argentina
MR Medicina Reumatologica
San Fernando, Argentina
Banksia Trials SA
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre
Clayton, Australia
SA Gastrointestinal Services
Kurraba Point, Australia
Macquarie University
Macquarie Island, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
New Lambton, Australia
Mater Misericordiae Hospital
South Brisbane, Australia
The Melbourne Gut Clinic Epworth Hospital
West Melbourne, Australia
Kepler Universitatsklinikum GmbH
Linz, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, Austria
Klinikum Wels Grieskirchen
Wels, Austria
Imelda Bonheiden
Bonheiden, Belgium
AZ Sint-Lucas
Brugge (Bruges), Belgium
UZ Brussel
Brussel (Bruxelles), Belgium
Cliniques Universitaires Saint Luc
Brussel (Bruxelles), Belgium
AZ Maria Middelares
Gent (Ghent), Belgium
Ghent University Hospital
Gent (Ghent), Belgium
ULB Erasme Ziekenhuis
Koekelberg/Brussel (Bruxelles), Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
CHC MontLegia
Liège, Belgium
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, Brazil
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Jaú, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Complexo Hospitalar de Niteroi
Niterói, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, Brazil
Pesquisare Saude
Santo André, Brazil
BR Trials
São Paulo, Brazil
Solare Trials
São Paulo, Brazil
Rocco And Nazato Servicos Medicos Ltda
São Paulo, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, Brazil
MHAT Sv. Karidad EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'
Sofia, Bulgaria
Diagnostic Consultative Center Neoclinic EAD
Sofia, Bulgaria
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment - Tsaritsa Yoanna - ISUL, EAD
Sofia, Bulgaria
DCC Convex EOOD
Sofia, Bulgaria
Acibadem City Clinic - Oncology Center
Sofia, Bulgaria
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Varna, Bulgaria
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)
Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
Charlton Digestive Disease Centre
Hamilton, Ontario, Canada
London Digestive Disease Institute
London, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, Canada
Clinique IMD
Montreal, Quebec, Canada
China Japan Friendship Hospital
Beijing, China
Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Changzhou No 2 Peoples Hospital
Changzhou, China
West China Hospital Si Chuan University
Chengdu, China
Chongqing General Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China