CompletedPhase 3

An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis

United States877 participantsStarted 2015-12-02

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

What they're measuring

Number of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)

Timeframe: From first dose to 90 days post last dose (Up to approximately 92 months)

Trial details

NCT IDNCT02531126

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-19

Results submitted2025-12-10

View on ClinicalTrials.gov More Ulcerative Colitis trials