Actively Recruiting
A Phase 3 Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of JNJ-78934804 Compared to Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Led by Janssen Research & Development, LLC · Updated on 2026-06-08
644
Participants Needed
6
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of JNJ-78934804 compared to guselkumab in participants with moderately to severely active ulcerative colitis (UC), a chronic condition causing inflammation and ulcers in the colon lining. This Phase 3, randomized, double-blind study aims to understand how well JNJ-78934804 works by week 48 for people who have not responded adequately to previous approved systemic treatments. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab, both given as subcutaneous injections. The treatment starts with induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks beginning at Week 12. If rescue criteria are met, participants receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then maintenance doses every 4 weeks starting Week 28. Those completing the 48-week double-blind phase and benefiting from treatment may join a long-term extension phase. During the study, participants will undergo assessments including clinical remission rates, endoscopic improvement, corticosteroid-free remission, fatigue response, abdominal pain remission, and quality of life measures at multiple time points. Safety monitoring for adverse events continues for up to approximately three years. The main outcome measured is the percentage of participants in clinical remission at Week 48, with several additional secondary outcomes also evaluated.
CONDITIONS
Brief Title
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ulcerative colitis established at least 12 weeks before screening confirmed by endoscopy and histopathology
- Moderately to severely active ulcerative colitis with a modified Mayo score of 5 to 9 at baseline
- Endoscopy subscore of 2 or higher from central review
- Inadequate response, loss of response, or intolerance to previous approved systemic therapies
You will not qualify if you...
- Isolated proctitis limited to the rectum or less than 20 centimeters from the anal verge
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis, or indications of Crohn's disease
- History or ongoing chronic or recurrent infectious disease
- Previous inadequate response, loss of response, allergy, hypersensitivity, or intolerance to guselkumab or golimumab
- Pregnancy, breastfeeding, or planning pregnancy or fathering a child during the study or within 6 months after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive active treatment with either JNJ-78934804 or Guselkumab administered subcutaneously. The treatment includes induction doses at Weeks 0, 4, and 8 followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria receive additional induction doses at Weeks 16, 20, and 24 followed by maintenance every 4 weeks starting at Week 28.
Visits at Weeks 0, 4, 8, 12, 16, 20, 24, and then every 4 weeks until Week 48
Duration - After Week 48, duration varies
Participants who complete the double-blind treatment phase and benefit from continued study intervention may enter the long-term extension phase for ongoing treatment and monitoring.
Visit schedule varies depending on extension phase protocol
Trial Site Locations
Total: 6 locations
1
Clinnova Research
Anaheim, California, United States, 92805
Actively Recruiting
2
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
3
GCP Clinical Research
Tampa, Florida, United States, 33609
Actively Recruiting
4
New York Gastroenterology Associates
New York, New York, United States, 10075
Actively Recruiting
5
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan, 892-0843
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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