A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

    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
  • EXCLUSION CRITERIA

    Exclusion Criteria:

    1. Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
    2. Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis

    Other protocol-defined inclusion/exclusion criteria apply

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition
    Crohn Disease
    Age (in years)
    18 - 75
    Phase
    Phase 3
    Participants needed
    485
    Est. Completion Date
    Mar 24, 2026
    Treatment type
    Interventional

    Sponsor
    Celgene
    ClinicalTrials.gov identifier
    NCT03464097
    Study number
    RPC01-3203

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