CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 544 enrolled
Drug / intervention
secukinumab +1 moredrug
Likely dose
secukinumab 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03713619
NCT03713619Phase 3Completed
CompareCT.gov

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).

Novartis Pharmaceuticals·interventional·Posted Oct 22, 2018·Updated Oct 9, 2024

In Brief

A Phase 3 clinical trial evaluating secukinumab and Placebo for Hidradenitis Suppurativa. Completed, enrolled 544 participants across 111 sites in 29 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHidradenitis Suppurativa
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartJan 31, 2019
Primary CompletionOct 1, 2021
Study CompletionJul 26, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.7 years ago

Interventions

secukinumabdrug

Secukinumab 300mg every 2 or every 4 weeks

Placebodrug

Placebo 300mg every 2 or every 4 weeks