A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) 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 2, Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) 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: * Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2 * Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segmen |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Janssen Research & Development, LLC |
| Locations | Chandler, Arizona, United States; Litchfield Park, Arizona, United States; Scottsdale, Arizona, United States; Anaheim, California, United States; Canoga Park, California, United States; Coronado, California, United States (+357 more sites) |
| Start date | 2025-10-03 |
| NCT ID | NCT07196722 |
| Official listing | https://clinicaltrials.gov/study/NCT07196722 |