At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 254 enrolled
Drug / intervention
Abrilumab +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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating Abrilumab and Placebo for Crohn's Disease. Completed, enrolled 254 participants across 84 sites in 12 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI \< 150) after treatment for 8 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Netherlands, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartDec 2012
Primary CompletionDec 2014
Study CompletionApr 2018
TodayJul 2026
First PostedOct 1, 2012
Enrollment StartDec 4, 2012
Primary CompletionDec 26, 2014
Study CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.8 years ago
Interventions
Abrilumabdrug
Administered by subcutaneous injection.
Placebodrug
Placebo matching to abrilumab administered by subcutaneous injection