At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 931 enrolled
Drug / intervention
placebo for risankizumab +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 of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating placebo for risankizumab, risankizumab IV, and 1 other intervention for Crohn's Disease. Completed, enrolled 931 participants across 475 sites in 44 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesArgentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionNov 2020
Study CompletionApr 2021
TodayJul 2026
First PostedApr 7, 2017
Enrollment StartMay 10, 2017
Primary CompletionNov 9, 2020
Study CompletionApr 14, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.2 years ago
Interventions
placebo for risankizumabdrug
Placebo for risankizumab administered by intravenous infusion
risankizumab IVdrug
Risankizumab administered by intravenous infusion
risankizumab SCdrug
Risankizumab administered by subcutaneous (SC) injection