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Recruiting

An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease - RPC01-3204

Updated: 22 May, 2023   |   ClinicalTrials.gov

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

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18-75

    Age Range

  • 279

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Administration of oral Ozanimod
Drug: Ozanimod

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: - Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies - Experience relapse or who complete the Maintenance Study - Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation Exclusion Criteria: - Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study - Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated - Is receiving treatment with any of the following drugs or interventions within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors Other protocol-defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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