RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease
- Autoimmune Disorder
- Crohn's Disease
Active, not recruiting
- Belgium
- Bulgaria
- Canada
- France
- Germany
- Hungary
- Poland
- Slovakia
- Spain
- United States
NCT05910528 2023-504265-23-00 GA45392
Trial Summary
This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RO7790121 (RVT-3101) in adult participants with moderate to severe active Crohn's disease.
A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RO7790121 for the Treatment of Subjects With Moderate to Severe Active Crohn's Disease
Eligibility Criteria
- Moderately to severely active CD as defined by CDAI and SES-CD, assessed by central read
- Elevated very soft or liquid stool frequency and/or abdominal pain
- Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
- Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease
- Short gut syndrome
- Presence of an ostomy or ileoanal pouch
- Bowel resection or diversion with ~6-months
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