Moderate to Severe Hidradenitis Suppurativa

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). This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268. Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260. Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR reponse at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

AIN457

AIN457 (Secukinumab)

Solution for injection in pre-filled syringe (PFS)

300

Primary Outcome Measures :
time to loss of response (LOR) in HiSCR reponders [ Time Frame: Weeks 52 - 104 ]
Loss of response is defined as:

at least a 50% increase in abscess and/or nodules count (AN) compared to the average AN count from the 3 previous visits and the increase was at least of 3 AN from the average AN count of the 3 previous visits.
at least a 30% increase in AN compared to the average AN count from the 3 previous visits with an increase of at least 2 AN from the average count of the 3 previous visits or a further increase in the AN count of at least 2 AN .


Secondary Outcome Measures :
Cumulative rate of subjects who experience a flare in core HiScr responders [ Time Frame: Week 104 ]
subjects who experience at least one flare by Week 104. flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.

subjects achieving NRS30 [ Time Frame: Week 104 ]
HS-related skin pain; subjects achieving NRS30 at week 104, defined as at least a 30% reduction and at least one unit reduction from baseline in the subject's Global Assessment of Skin Pain

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.