At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 159 enrolled
Drug / intervention
placebo for risankizumab +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 48 Weeks, Phase II, Randomized, Double-blind, Placebo-controlled, Proof of Concept and Dose Finding Study of Three Different Dose Regimens of BI 655066 Administered Subcutaneously in Patients With Ankylosing Spondylitis.
In Brief
A Phase 2 clinical trial evaluating placebo for risankizumab and risankizumab for Ankylosing Spondylitis (AS). Completed, enrolled 159 participants.
Detailed Summary
The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis (AS)
Countries--
CollaboratorsBoehringer Ingelheim
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartJan 2014
Primary CompletionMar 2015
Study CompletionJul 2016
TodayJul 2026
First PostedJan 28, 2014
Enrollment StartJan 28, 2014
Primary CompletionMar 5, 2015
Study CompletionJul 25, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.4 years ago
Interventions
placebo for risankizumabdrug
Placebo for risankizumab administered by subcutaneous (SC) injection
risankizumabdrug
Risankizumab administered by subcutaneous (SC) injection