Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Crohn Disease Clinical Trial

NCT03467958 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with crohn disease?

You may be eligible to participate in a crohn disease clinical trial.

Have you or your loved ones been diagnosed with crohn disease? You may be eligible to participate in a crohn disease clinical trial.

Recruiting

Male & Female

18 - 75

Years old

This study is looking to recruit 1200 Participants

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

Show me more details

Details for the study

Brief Title

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

Official Title

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

Brief Summary

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

Treatments and/or Procedures

Ozanimod

Specified dose on specified days

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Proportion of participants with a CDAI score of < 150

The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinicalactivity of CD

Up to 234 Weeks

Study 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