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

Hidradenitis Suppurativa Clinical Trial

— SUNSHINE  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713619
• Other study ID #: CAIN457M2301
• Secondary ID: 2018-002063-26
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2019
• Est. completion date: July 26, 2022

Study information

• Verified date: January 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: July 26, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.

• Male and female patients = 18 years of age.

• Diagnosis of HS = 1 year prior to baseline.

• Patients with moderate to severe HS defined as:

• A total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules AND

• Inflammatory lesions should affect at least 2 distinct anatomic areas

• Patients agree to daily use of topical over-the-counter antiseptics on the areas affected by HS lesions while on study treatment.

Exclusion Criteria:

• Total fistulae count = 20 at baseline.

• Any other active skin disease or condition that may interfere with assessment of HS.

• Active ongoing inflammatory diseases other than HS that require treatment with prohibited medications.

• Use or planned use of prohibited treatment. Washout periods detailed in the protocol have to be adhered to.

• History of hypersensitivity to any of the study drug constituents.

• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).

• Pregnant or lactating women.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• secukinumab
Secukinumab 300mg every 2 or every 4 weeks
• Placebo
Placebo 300mg every 2 or every 4 weeks

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	La Plata	Buenos Aires
Australia	Novartis Investigative Site	Benowa	Queensland
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Phillip	Australian Capital Territory
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Bruxelles	Brussels
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Peterborough	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Czechia	Novartis Investigative Site	Plzen
Czechia	Novartis Investigative Site	Prague	Prague 1
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Paris Cedex 10
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Langenau
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Potsdam
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Pecs
India	Novartis Investigative Site	Mangalore	Karnataka
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	New Delhi	Delhi
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Pisa	PI
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Koshigaya-city	Saitama
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nakagami	Okinawa
Japan	Novartis Investigative Site	Osaka
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Philippines	Novartis Investigative Site	Davao City	Davao
Philippines	Novartis Investigative Site	Las Pinas
Philippines	Novartis Investigative Site	Quezon City	Metro Manila
Poland	Novartis Investigative Site	Ossy
Poland	Novartis Investigative Site	Warszawa	Mazowian
Poland	Novartis Investigative Site	Wroclaw
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Matosinhos
Portugal	Novartis Investigative Site	Porto
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Martin
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cadiz	Andalucia
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Pontevedra
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Geneve
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Gaziantep
United Kingdom	Novartis Investigative Site	Barnsley
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Leeds	West Yorkshire
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Salford	Manchester
United States	Novartis Investigative Site	Anaheim	California
United States	Novartis Investigative Site	Birmingham	Alabama
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Chapel Hill	North Carolina
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Fairborn	Ohio
United States	Novartis Investigative Site	Goodlettsville	Tennessee
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	New Brighton	Minnesota
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Rogers	Arkansas
United States	Novartis Investigative Site	Saint Joseph	Missouri
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Skokie	Illinois
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	West Dundee	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Philippines,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR)	HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.	16 weeks
Secondary	Proportion of patients with Hidradenitis Suppurativa (HS) flares	Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline	16 weeks
Secondary	Participants achieving NRS30	HS-related skin pain Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 [no skin pain] to 10 [worst skin pain])	16 weeks
Secondary	Percentage change in AN count	Percent change in abscesses and inflammatory nodules (AN) count	16 weeks