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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: A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center 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
2030-10-30
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Guselkumab
Guselkumab will be administered subcutaneously.
Locations (26)
Clinnova Research
Anaheim, California, United States
Gastro SB Clinic
Chula Vista, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
New York Gastroenterology Associates
New York, New York, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
SA Gastrointestinal Services
Kurralta Park, Australia
GI Research Institute (G.I.R.I.)
Vancouver, British Columbia, Canada
London Digestive Disease Institute
London, Ontario, Canada
Rambam Medical Center
Haifa, Israel
Bnai Zion Medical Center
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Matsuda Hospital
Hamamatsu, Japan
National Hospital Organization Mito Medical Center
Higashi-Ibaraki, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan
Oita Red Cross Hospital
Ōita, Japan
Saga University Hospital
Saga, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Japan
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Malaysia
Sanko Universitesi Hastanesi
Gaziantep, Turkey (Türkiye)
Bezmialem University Medical Faculty
Istanbul, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, Turkey (Türkiye)