At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 170 enrolled
Drug / intervention
Apremilast +1 moredrug
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 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Apremilast and Placebo for Ulcerative Colitis. Completed, enrolled 170 participants across 99 sites in 14 countries.
Detailed Summary
The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily \[BID\] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartJan 2015
Primary CompletionSep 2017
Study CompletionJun 2019
TodayJul 2026
First PostedNov 13, 2014
Enrollment StartJan 8, 2015
Primary CompletionSep 25, 2017
Study CompletionJun 3, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.6 years ago
Interventions
Apremilastdrug
Placebodrug