Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis UCSD
Dates
study started
completion around

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: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • Ucsd Medical Center completed
    La Jolla California 92037 United States
  • UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit accepting new patients
    Sacramento California 95817 United States
  • Local Institution - 110 completed
    Los Angeles California 90067 United States
  • Local Institution - 281 completed
    San Francisco California 94158 United States
  • Matrix Clinical Research Inc completed
    Los Angeles California 90048 United States
  • Southern California Research Institute Medical Group, Inc. completed
    Los Angeles California 90045 United States
  • Medical Associates Research Group accepting new patients
    San Diego California 92123 United States
  • Local Institution - 061 completed
    Los Angeles California 90027 United States
  • Valley View Internal Medicine accepting new patients
    Garden Grove California 92843 United States
  • ABS Health, LLC completed
    Mission Viejo California 92691 United States

Details

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