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

Hidradenitis Suppurativa Clinical Trial

— SUNRISE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713632
• Other study ID #: CAIN457M2302
• Secondary ID: 2018-002062-39
• Status: Completed
• Phase: Phase 3
• Start date: February 25, 2019
• Est. completion date: July 19, 2022

Study information

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

Clinical Trial 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.

Description:

This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 545
• Est. completion date: July 19, 2022
• Est. primary completion date: September 23, 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	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Capital Federal
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Liege
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	Drummondville	Quebec
Canada	Novartis Investigative Site	Richmond Hill	Ontario
Canada	Novartis Investigative Site	Saint Jerome	Quebec
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Bogota
Croatia	Novartis Investigative Site	Zagreb	HRV
Czechia	Novartis Investigative Site	Jihlava
Czechia	Novartis Investigative Site	Usti nad Labem	Czech Republic
Denmark	Novartis Investigative Site	Aarhus
Denmark	Novartis Investigative Site	Copenhagen NV
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Limoges	Haute Vienne
France	Novartis Investigative Site	Martigues
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Rouen Cedex
France	Novartis Investigative Site	Saint Mande
France	Novartis Investigative Site	Saint-Etienne
France	Novartis Investigative Site	Toulon Cedex 9	Val De Marne
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dessau Rosslau
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki	GR
Guatemala	Novartis Investigative Site	Guatemala City
Guatemala	Novartis Investigative Site	Guatemala City
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvar
Hungary	Novartis Investigative Site	Szeged
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Navi Mumbai	Maharashtra
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Cona	FE
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
Lebanon	Novartis Investigative Site	Saida
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Vilnius	Vilniaus
Malaysia	Novartis Investigative Site	Johor Bahru
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Novartis Investigative Site	Penang
Netherlands	Novartis Investigative Site	Bergen op Zoom
Philippines	Novartis Investigative Site	Makati City
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Rzeszow
Poland	Novartis Investigative Site	Warszawa
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Smolensk
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Presov
South Africa	Novartis Investigative Site	Pretoria	Gauteng
South Africa	Novartis Investigative Site	Soweto	Gauteng
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Granada
Spain	Novartis Investigative Site	Las Palmas de Gran Canaria
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Manises	Valencia
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Zurich
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Talas / Kayseri
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Dudley	West Midlands
United Kingdom	Novartis Investigative Site	Harrogate
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United States	Novartis Investigative Site	Bellaire	Texas
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Coral Gables	Florida
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Norfolk	Virginia
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Pflugerville	Texas
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Sandy Springs	Georgia
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Whittier	California
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Belgium,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Guatemala,  Hungary,  India,  Israel,  Italy,  Lebanon,  Lithuania,  Malaysia,  Netherlands,  Philippines,  Poland,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)	HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration.; This endpoint was analyzed by logistic regression.	16 weeks
Secondary	Percentage Change From Baseline in AN Count	Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.	Baseline, 16 weeks
Secondary	Percentage of Participants With Hidradenitis Suppurativa (HS) Flares	Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline.; This endpoint was analyzed by logistic regression.	16 weeks
Secondary	Percentage of Participants Achieving NRS30	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]).; This endpoint was analyzed by logistic regression.	16 weeks