Comparison of JNJ-78934804 and Guselkumab Treatments in Adults with Moderately to Severely Active Crohns Disease

What this Trial Is About

Researchers are evaluating how well JNJ-78934804 works and how safe it is compared to guselkumab in participants with moderately to severely active Crohns disease, a long-term and progressive condition affecting the intestine. This Phase 3 trial aims to assess clinical remission and endoscopic remission at Week 48, focusing on treatment efficacy and safety. Participants are randomly assigned to receive either JNJ-78934804 or guselkumab. Both treatments involve induction doses at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks starting at Week 12. Participants meeting rescue criteria will receive additional induction doses of JNJ-78934804 at Weeks 16, 20, and 24, with maintenance doses continuing every 4 weeks from Week 28. Those completing the double-blind phase at Week 48 may enter a long-term extension phase if the investigator believes they may benefit. During the study, participants will be monitored for clinical and endoscopic remission, deep remission, corticosteroid-free remission, and patient-reported outcomes up to Week 48. Researchers will also track adverse events for up to approximately three years. Assessments include symptom scores, endoscopy reviews, and quality-of-life questionnaires to evaluate the treatments effects and safety throughout the trial.

A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease