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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
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

NCT04179175

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Hidradenitis Suppurativa

Interventions: secukinumab, secukinumab

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Colombia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 had received 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
Locations (191)
  • Rogers, Arkansas, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Whittier, California, United States
  • Coral Gables, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Sandy Springs, Georgia, United States
  • Glenview, Illinois, United States
  • West Dundee, Illinois, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • New Brighton, Minnesota, United States
  • Saint Joseph, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Fairborn, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Pflugerville, Texas, United States
  • San Antonio, Texas, United States
  • Norfolk, Virginia, United States
  • Buenos Aires, Buenos Aires, Argentina
  • + 161 more on CT.gov