A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Acti
The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
| Condition(s) | Crohn Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract). |
| Who can participate | Inclusion criteria: * Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy * Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450 * Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, result |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Janssen Research & Development, LLC |
| Locations | Dothan, Alabama, United States; Anaheim, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Colorado Springs, Colorado, United States (+24 more sites) |
| Start date | 2026-04-21 |
| NCT ID | NCT07499232 |
| Official listing | https://clinicaltrials.gov/study/NCT07499232 |