At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 359 enrolled
Drug / intervention
Abrilumab +1 morebiological
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 Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating Abrilumab and Placebo for Ulcerative Colitis. Completed, enrolled 359 participants across 123 sites in 20 countries.
Detailed Summary
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Russia, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartNov 2012
Primary CompletionJul 2015
Study CompletionApr 2018
TodayJul 2026
First PostedSep 27, 2012
Enrollment StartNov 16, 2012
Primary CompletionJul 13, 2015
Study CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.8 years ago
Interventions
Abrilumabbiological
Administered by subcutaneous injection.
Placebodrug
Placebo matching to abrilumab administered by subcutaneous injection