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
Key facts
- Where
- Bellaire, Boston, Chapel Hill, Charleston, Coral Gables, Dallas, Fairborn, Glenview, Indianapolis, Miami, New Brighton, New York, Norfolk, Omaha, Pflugerville, Pittsburgh, Rogers, Saint Joseph, San Antonio, San Diego, Sandy Springs, St Louis, Tampa, West Dundee, and Whittier, United StatesSee the 29 sites
- Phase
- Phase 3
Where in United States
- Bellaire Dermatology AssociatesBellaire, United StatesNo longer taking part
- Beth Israel Deaconess Med CenterBoston, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- University of North CarolinaChapel Hill, United StatesNo longer taking part
- Clinical Research Ctr of CarolinasCharleston, United StatesNo longer taking part
- Florida Academic Centers Research and Education, LLCCoral Gables, United StatesNo longer taking part
- MDRI Baylor UniversityDallas, United StatesNo longer taking part
- Wright State UniversityFairborn, United StatesNo longer taking part
- Endeavor HealthGlenview, United StatesNo longer taking part
- Dawes Fretzin Clinical Rea GroupIndianapolis, United StatesNo longer taking part
- University of MiamiHealth SystemMiami, United StatesNo longer taking part
- Minnesota Clinical Study CenterNew Brighton, United StatesNo longer taking part
- Icahn School Of Med At Mount SinaiNew York, United StatesNo longer taking part
- Virginia Clinical ResearchNorfolk, United StatesNo longer taking part
- Skin Specialists, PCOmaha, United StatesNo longer taking part
- Austin Inst for Clinical ResearchPflugerville, United StatesNo longer taking part
- UP Medical Center H SystemPittsburgh, United StatesNo longer taking part
- Northwest Arkansas CenterRogers, United StatesNo longer taking part
- Medisearch Clinical TrialsSaint Joseph, United StatesNo longer taking part
- Dr. Stephen Miller, MDPASan Antonio, United StatesNo longer taking part
- MedDerm AssociatesSan Diego, United StatesNo longer taking part
- University Clinical TrialsSan Diego, United StatesNo longer taking part
- Advanced Medical ResearchSandy Springs, United StatesNo longer taking part
- St Louis U Clinical TrialsSt Louis, United StatesNo longer taking part
- WA Uni School Of MedSt Louis, United StatesNo longer taking part
- Olympian Clinical ResearchTampa, United StatesNo longer taking part
- University of South FloridaTampa, United StatesNo longer taking part
- Dundee DermatologyWest Dundee, United StatesNo longer taking part
- Southern California Skin and LaserWhittier, United StatesNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04179175EU 2023-508956-20-00
- Record updated
- 21 August 2026
- Original description
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).Read full original descriptionShow less
A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa
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).
Inclusion: 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.
Exclusion: current sever progressive or uncontrolled disease which renders the subject unsuitable for the study; 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.