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

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

Brief Summary:
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 Description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 541 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


Study Type: Interventional (Clinical Trial)
Actual Enrollment: 544 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter Study Assessing Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability of 2 Subcutaneous Secukinumab Dose Regimens in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (SUNRISE)
Actual Study Start Date: February 25, 2019
Estimated Primary Completion Date: September 27, 2021
Estimated Study Completion Date: August 1, 2022

Arm:
- Active Comparator: Secukinumab 1
- Active Comparator: Secukinumab 2
- Placebo Comparator: Placebo 1
- Placebo Comparator: Placebo 2

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