Summary

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

Description

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis. Only those participants who have previously participated in a trial of RPC1063, being either RPC01-3101 or completed at least 1 year of the open-label period of RPC01-202 will be eligible.

Official Title

A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

Details

This is an extension study trial. Eligible participants from the RPC01-3101 and RPC01-202 trials were able to roll-over in this trial to receive study medication until March 2023 or until the Sponsor discontinues the development program, whichever comes first.

Keywords

Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer Ozanimod RPC1063 RPC0163 (Ozanimod)

Eligibility

For people ages 18-75

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• Previously participated in a trial of RPC1063 and meets the criteria for participation in the open-label extension as outlined in the prior trial

Exclusion Criteria:

  • Receiving treatment with breast cancer resistance protein inhibitors
  • Clinically relevant cardiovascular conditions
  • Liver function impairment

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • University of California at San Francisco (PARENT)
    San Francisco California 94115 United States
  • Local Institution - 230
    Lancaster California 93534 United States
  • OM Research
    Lancaster California 93534 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT02531126
Phase
Phase 3 research study
Study Type
Interventional
Participants
At least 878 people participating
Last Updated