NCT03713619

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

A Randomized, Double-blind, Multi-center 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 (SUNSHINE).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 544 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was 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 also assessed the safety and tolerability of secukinumab.

Detailed description

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in 541 patients with moderate to severe HS. The study consisted 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 was an optional extension study (NCT04179175). Adult males and females with moderate to severe HS were included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included. In Treatment Period 1, participants were randomized to secukinumab Q2W, secukinumab Q4W, placebo Q2W or placebo Q4W in 1:1:0.5:0.5 ratio. In Treatment Period 2, at the Week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose. At the Week 16 visit, subjects initially randomized to placebo were switched to one of the two active dose regimens (secukinumab Q2W or Q4W), while subjects randomized to secukinumab during Treatment Period 1 continued on the same dose. The primary objective was to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; secondary objectives were 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 was collected, along with Patient Reported Outcomes.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	secukinumab	Secukinumab 300mg every 2 or every 4 weeks
DRUG	Placebo	Placebo 300mg every 2 or every 4 weeks

Timeline

• Start date: 2019-01-31
• Primary completion: 2021-10-01
• Completion: 2022-07-26
• First posted: 2018-10-22
• Last updated: 2024-10-09
• Results posted: 2024-09-25

Locations

111 sites across 29 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Philippines, Poland, Portugal, Russia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study