At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 226 enrolled
Drug / intervention
Secukinumab +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 Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis
In Brief
A Phase 3 clinical trial evaluating Secukinumab and Placebo secukinumab for Spondylitis, Ankylosing. Completed, enrolled 226 participants across 57 sites in 10 countries.
Detailed Summary
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpondylitis, Ankylosing
CountriesBelgium, Czechia, Germany, Greece, Mexico, Portugal, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartJan 2014
Primary CompletionFeb 2015
Study CompletionDec 2017
TodayJul 2026
First PostedDec 11, 2013
Enrollment StartJan 14, 2014
Primary CompletionFeb 23, 2015
Study CompletionDec 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.6 years ago
Interventions
Secukinumabdrug
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
Placebo secukinumabdrug
Placebo to AIN457 (Secukinumab)