At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 618 enrolled
Drug / intervention
placebo for risankizumab IV +2 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
In Brief
A Phase 3 clinical trial evaluating placebo for risankizumab IV, risankizumab SC, and 1 other intervention for Crohn's Disease. Completed, enrolled 618 participants across 403 sites in 43 countries.
Detailed Summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, Estonia, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartDec 2017
Primary CompletionNov 2020
Study CompletionMay 2021
TodayJul 2026
First PostedApr 7, 2017
Enrollment StartDec 18, 2017
Primary CompletionNov 30, 2020
Study CompletionMay 19, 2021
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.2 years ago
Interventions
placebo for risankizumab IVdrug
placebo for risankizumab administered as intravenous (IV) infusion.
risankizumab SCdrug
risankizumab administered by subcutaneous (SC) injection
risankizumab IVdrug
risankizumab administered as intravenous (IV) infusion.