Overview

Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Status:
Recruiting

Trial end date:
2026-07-28

Target enrollment:
0

Participant gender:
All

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

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Antibodies, Monoclonal

Criteria

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.