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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03713632
Other study ID # CAIN457M2302
Secondary ID 2018-002062-39
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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