At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 433 enrolled
Drug / intervention
Etrasimod +1 moredrug
Likely dose
Etrasimod 2 mgfrom 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, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Etrasimod and Placebo for Ulcerative Colitis. Completed, enrolled 433 participants across 315 sites in 40 countries.
Detailed Summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Latvia, Lebanon, Lithuania, Mexico, Moldova, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartJun 2019
Primary CompletionFeb 2022
Study CompletionFeb 2022
TodayJul 2026
First PostedMay 10, 2019
Enrollment StartJun 13, 2019
Primary CompletionFeb 8, 2022
Study CompletionFeb 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.1 years ago
Interventions
Etrasimoddrug
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Placebodrug
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment