An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
Exclusion Criteria:
- Receiving treatment with breast cancer resistance protein inhibitors
- Clinically relevant cardiovascular conditions
- Liver function impairment
Other protocol-defined inclusion/exclusion criteria apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Ulcerative Colitis
Age (in years)
18 - 75
Phase
Phase 3
Participants needed
878
Est. Completion Date
Feb 27, 2025
Treatment type
Interventional
Sponsor
Celgene
ClinicalTrials.gov identifier
NCT02531126
Study number
RPC01-3102
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