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Trial ID RPC01-3204  |   NCT03467958

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

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18-75
    Age Range
  • 194
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

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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: CYP2C8 inducers; Monoamine oxidase inhibitors Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Administration of oral Ozanimod

ASSIGNED INTERVENTION
  • Drug: Ozanimod
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