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

Prior treatment

• For prohibited medications and exceptions please see Section 8.7 of the protocol.
• Bowel resection or diversion within approximately 6 months prior to the Baseline (W1, D1) Visit.

Other illness

• Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease.

Other

• Presence of an ostomy or ileoanal pouch.

• Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analysis.
• Participants of any gender-definition, aged 18-75 years (or at age of consent per local guidelines if ≥18 years).
• Must have confirmed diagnosis of ileal, ileocolonic or colonic CD for at least 12 weeks (approximately 3 months) prior to the Baseline (W1, D1) Visit. Appropriate documentation of biopsy-proven CD must be available and recorded.
• CDAI score 220-450 determined at Screening, CDAI to be assessed prior to Screening colonoscopy.