Active, Not Recruiting

Trial ID RPC01-3203 | NCT03464097

A Placebo-Controlled Study of Oral Ozanimod as Maintenance 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

This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study

Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis Other protocol-defined inclusion/exclusion criteria apply

Additional Information *

Study Arms

Experimental: Ozanimod

ASSIGNED INTERVENTION

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION