For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. written informed consent must be obtained before any assessment is performed
  2. 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

  1. protocol deviation in the core study which will prevent the meaningful analysis of the extension study
  2. ongoing or planned use of prohibited HS or non-HS treatment
  3. participation in the extension could expose the subject to an undue safety risk
  4. current sever progressive or uncontrolled disease which renders the subject unsuitable for the study.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Contition

Hidradenitis Suppurativa

Age

18+

Phase

Phase 3

Participants needed

856

Est. Completion Date

Jul 2026

Treatment type

Interventional


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04179175

Study number

CAIN457M2301E1

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