At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 354 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, 12-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 354 participants across 407 sites in 41 countries.
Detailed Summary
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Lebanon, Lithuania, Mexico, Moldova, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 2019
Enrollment StartSep 2020
Primary CompletionDec 2021
TodayJul 2026
First PostedJun 24, 2019
Enrollment StartSep 15, 2020
Primary CompletionDec 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.0 years ago
Interventions
Etrasimoddrug
Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period
Placebodrug
Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period