Afimkibart (RO7790121) for the Treatment of 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

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Inclusion 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

Exclusion Criteria:

• 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