At a glance
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A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis
In Brief
A Phase 3 clinical trial evaluating secukinumab and placebo for Juvenile Psoriatic Arthritis and Enthesitis-related Arthritis. Completed, enrolled 86 participants across 31 sites in 10 countries.
Detailed Summary
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period) consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment Period 2
Study Details
Timeline
Interventions
secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
Matched placebo to AIN457 for use in the double blind Treatment Period 2