Last updated on July 2019

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)


Brief description of study

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

Detailed Study Description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 471 patients with moderate to severe HS. The study consists of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there will be an optional extension study. Adult males and females with moderate to severe HS will be included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing will be once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included The primary objective is to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; primary secondary objectives are to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data will be collected, along with Patient Reported Outcomes

Clinical Study Identifier: NCT03713632

Find a site near you

Start Over

Novartis Investigative Site

Laguna Niguel, CA United States
  Connect »

Novartis Investigative Site

San Diego, CA United States
  Connect »

Novartis Investigative Site

Indianapolis, IN United States
  Connect »

Novartis Investigative Site

Saint Louis, MO United States
  Connect »

Novartis Investigative Site

New York, NY United States
  Connect »

Novartis Investigative Site

Bellaire, TX United States
  Connect »

Novartis Investigative Site

Pflugerville, TX United States
  Connect »

Novartis Investigative Site

Norfolk, VA United States
  Connect »

Novartis Investigative Site

Chelyabinsk, Russian Federation
  Connect »

Novartis Investigative Site

Saint Petersburg, Russian Federation
  Connect »

Novartis Investigative Site

Smolensk, Russian Federation
  Connect »

Novartis Investigative Site

St Petersburg, Russian Federation
  Connect »

Novartis Investigative Site

Banska Bystrica, Slovakia
  Connect »

Novartis Investigative Site

Las Palmas de Gran Canaria, Spain
  Connect »

Novartis Investigative Site

Birmingham, United Kingdom
  Connect »

Novartis Investigative Site

Harrogate, United Kingdom
  Connect »