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Trial ID RPC01-3201  |   NCT03440372

Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18-75
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.

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Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Administration of oral Ozanimod

ASSIGNED INTERVENTION
  • Drug: Ozanimod

Study Arms

Placebo Comparator: Administration of Placebo

ASSIGNED INTERVENTION
  • Other: Placebo

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