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

clipboard-pencil

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.
user-3

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


    pin location

    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.
    Phone iconCall please email:Email iconEmail Study Center

    Study 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 NCT Identifier
    NCT03464097
    Study Number
    RPC01-3203

    Understanding Clinical Trials

    Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?