A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study Comparing Guselkumab and Risankizumab in Moderately to Severely Active Crohn's Disease

What this Trial Is About

Researchers are evaluating how well guselkumab works compared to risankizumab in adults with moderately to severely active Crohn's Disease, a long-term condition causing significant inflammation in the intestines. This Phase 3b study aims to compare the effectiveness and safety of these two treatments to better understand their impacts on this condition. The trial is sponsored by Janssen Research & Development, LLC and uses a randomized, open-label design. Participants will be assigned to one of two groups. One group will receive guselkumab as an injection under the skin at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks through Week 52. The other group will receive risankizumab initially through intravenous infusion at Weeks 0, 4, and 8, then maintenance injections every 8 weeks through Week 52. Both treatments are given over one year to monitor their effects. During the study, participants will be monitored for deep remission at Week 52, alongside several secondary outcomes including clinical remission, endoscopic response, and steroid-free remission. The study team will track laboratory results and any adverse events up to Week 165. Participants will undergo various assessments including endoscopic exams at screening and throughout the study to evaluate their disease activity and response to treatment. The trial is expected to run until December 2030.

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease