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Phase III

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

  • Study HIC#:2000024563
  • Last Updated:01/31/2022

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

  • Age18 years - 75 years
  • GenderBoth
  • Start Date08/11/2021
  • End Date06/26/2026

Trial Purpose and Description

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

Eligibility Criteria

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

Principal Investigator

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