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
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 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 AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).
Mar 18, 2020
Aug 18, 2026
18 Years and older (Adult, Older Adult)
secukinumab 300mg every 2 or every 4 weeks
written informed consent must be obtained before any assessment is performed
subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302)and have been receiving secukinumab treatment during Treatment Period 2
protocol deviation in the core study which will prevent the meaningful analysis of the extension study
ongoing or planned use of prohibited HS or non-HS treatment
participation in the extension could expose the subject to an undue safety risk
current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.