Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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).
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.