At a glance
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A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa
In Brief
A Phase 3 clinical trial evaluating secukinumab for Hidradenitis Suppurativa. Active but no longer recruiting, targeting 703 participants across 191 sites in 38 countries.
Detailed Summary
The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of Secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).
Study Details
Timeline
Interventions
secukinumab 300mg every 2 weeks
secukinumab 300mg every 4 weeks