Comparing JNJ-78934804 and Guselkumab for Moderately to Severely Active Ulcerative Colitis Treatment

What this Trial Is About

Researchers are evaluating the effectiveness and safety of JNJ-78934804 compared to guselkumab in people with moderately to severely active ulcerative colitis UC, a chronic condition where the colon lining becomes inflamed and develops ulcers. This Phase 3 study aims to measure clinical remission and other health improvements by Week 48. Participants receive an induction dose of either JNJ-78934804 or guselkumab at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting Week 12. Those meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, then maintenance doses every 4 weeks from Week 28. After completing the 48-week double-blind treatment phase, participants benefiting from the intervention may join a long-term extension phase. Throughout the study, participants will be monitored for clinical remission, endoscopic improvement, corticosteroid-free remission, fatigue, abdominal pain, quality of life, and mental health responses. Safety is assessed by tracking adverse events up to about 3 years. The study involves randomized assignment and double-blinding, with all treatments given by subcutaneous injection. Participation may last up to several years including follow-up and extension phases.

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis