RecruitingRecruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
NCT07577856 · Janssen Research & Development, LLC
In plain English
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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
About this study
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).
Eligibility criteria
Inclusion criteria:
* Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
* Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
* An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
* Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
Exclusion criteria:
* Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
* Has a history of or ongoing chronic or recurrent infectious disease
* Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
* Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention
Study design
Enrollment target: 644 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-23
Estimated completion: 2030-10-30
Last updated: 2026-07-06
Interventions
Drug: JNJ-78934804Drug: Guselkumab
Primary outcomes
- • Percentage of Participants in Clinical Remission at Week 48 (At Week 48)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (26)
Clinnova ResearchRecruiting
Anaheim, California, United States
Gastro SB ClinicRecruiting
Chula Vista, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
Southern Star Research Institute, LLCRecruiting
San Antonio, Texas, United States
SA Gastrointestinal ServicesRecruiting
Kurralta Park, Australia
GI Research Institute (G.I.R.I.)Recruiting
Vancouver, British Columbia, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
Rambam Medical CenterRecruiting
Haifa, Israel
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Matsuda HospitalRecruiting
Hamamatsu, Japan
National Hospital Organization Mito Medical CenterRecruiting
Higashi-Ibaraki, Japan
Kagoshima IBD Gastroenterology ClinicRecruiting
Kagoshima, Japan
Oita Red Cross HospitalRecruiting
Ōita, Japan
Saga University HospitalRecruiting
Saga, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
Sapporo, Japan
Hospital Sultanah Nur ZahirahRecruiting
Kuala Terengganu, Malaysia
Sanko Universitesi HastanesiRecruiting
Gaziantep, Turkey (Türkiye)
Bezmialem University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Kocaeli University Medical FacultyRecruiting
Kocaeli, Turkey (Türkiye)
Mersin University Medical FacultyRecruiting
Mersin, Turkey (Türkiye)