At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
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 Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy
In Brief
A Phase 2 clinical trial evaluating risankizumab IV, risankizumab SC, and 1 other intervention for Crohn Disease. Completed, enrolled 121 participants.
Detailed Summary
This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled, parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
Countries--
CollaboratorsBoehringer Ingelheim
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionDec 2015
Study CompletionNov 2016
TodayJul 2026
First PostedJan 9, 2014
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.5 years ago
Interventions
risankizumab IVdrug
risankizumab administered by IV infusion
risankizumab SCdrug
risankizumab administered by SC injection
Placebodrug
Placebo for risankizumab administered by IV infusion