At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 877 enrolled
Drug / intervention
RPC1063drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating RPC1063 for Ulcerative Colitis. Completed, enrolled 877 participants across 41 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Belarus, Belgium, Bulgaria, Canada, Croatia, Czechia, Germany, Greece, Hungary, Israel, Italy, Moldova, Poland, Romania, Slovakia, South Korea, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartDec 2015
Primary CompletionDec 2024
TodayJul 2026
First PostedAug 24, 2015
Enrollment StartDec 2, 2015
Primary CompletionDec 19, 2024
TodayJul 2, 2026
Enrollment to primary: 9.0 yearsPosted 10.9 years ago
Interventions
RPC1063drug