Recruiting
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease - RPC01-3201
Updated: 15 September, 2023 | ClinicalTrials.gov
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Recruiting
Inclusion Criteria: - Crohn's disease for ≥ 3 months on endoscopy and on histological exam - Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies - Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 - An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points - Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease) Exclusion Criteria: - Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention - Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition - Current stoma, ileal-anal pouch anastomosis, or fistula Other protocol-defined inclusion/exclusion criteria apply
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