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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (HiSCR response) 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 CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

Key facts

Study ID

NCT04179175

Run by

Novartis Pharmaceuticals

People needed

703

Starts

2020-03-18

Expected to finish

2026-07-15

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 had received secukinumab treatment during Treatment Period 2

You may not qualify if…

• 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

Where it is running

• MedDerm Associates — San Diego, California, United States
• University Clinical Trials — San Diego, California, United States
• Southern California Skin and Laser — Whittier, California, United States
• Florida Academic Centers Research and Education LLC — Coral Gables, Florida, United States
• University of MiamiHealth System — Miami, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• University Of South Florida — Tampa, Florida, United States
• Advanced Medical Research — Sandy Springs, Georgia, United States
• Endeavor Health — Glenview, Illinois, United States
• Dundee Dermatology — West Dundee, Illinois, United States
• Dawes Fretzin Clinical Rea Group — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Center — Boston, Massachusetts, United States
• Minnesota Clinical Study Center — New Brighton, Minnesota, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• St Louis U Clinical Trials — St Louis, Missouri, United States
• WA Uni School Of Med — St Louis, Missouri, United States
• Skin Specialists PC — Omaha, Nebraska, United States
• Icahn School Of Med At Mount Sinai — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Wright State University — Fairborn, Ohio, United States
• UP Medical Center H System — Pittsburgh, Pennsylvania, United States
• Clinical Research Ctr of Carolinas — Charleston, South Carolina, United States
• Bellaire Dermatology Associates — Bellaire, Texas, United States
• Northwest Arkansas Center — Rogers, Arkansas, United States

Full record on ClinicalTrials.gov

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