CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 545 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/NCT03713632
NCT03713632Phase 3Completed
CompareCT.gov

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)

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 545 participants across 108 sites in 32 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 assessed the safety and tolerability of secukinumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHidradenitis Suppurativa
CountriesArgentina, Belgium, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Lebanon, Lithuania, Malaysia, Netherlands, Philippines, Poland, Russia, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 22, 2018
Enrollment StartFeb 25, 2019
Primary CompletionSep 23, 2021
Study CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.7 years ago

Interventions

Secukinumabdrug

Secukinumab 300mg every 2 or every 4 weeks

Placebodrug

Placebo 300mg every 2 or every 4 weeks