Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This is an extension study to evaluate safety and efficacy of ozanimod in participants with 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

Keywords

Crohn Disease Crohn's Disease Oral Ozanimod Moderately active Severely active RPC01 RPC01-3204 Administration of oral Ozanimod

Eligibility

For people ages 18-75

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

Locations

  • UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit accepting new patients
    Sacramento California 95817 United States
  • VA Northern California Health Care System not yet accepting patients
    Mather California 95655 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting Sign up for this study
ID
NCT03467958
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1200 study participants
Last Updated