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

  • Interventional
  • Recruiting
  • NCT03467958
Eligibility Details Visit Clinicaltrials.gov

A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

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

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03467958

IRB#IRB18-0514

Lead SponsorCelgene

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting