At a glance
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A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis
In Brief
A Phase 3 clinical trial evaluating Secukinumab and Placebo for Spondylitis, Ankylosing. Completed, enrolled 350 participants across 90 sites in 19 countries.
Detailed Summary
The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.
Study Details
Timeline
Interventions
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio