Extension Study to Assess Effects of Non-interrupted Versus Interrupted and Long Term Treatment of Two Dose Regimes of Secukinumab in Subjects With Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04179175
• Other study ID #: CAIN457M2301E1
• Secondary ID: 2019-003230-17
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 18, 2020
• Est. completion date: July 15, 2026

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this extension study is to evaluate maintenance of HiSCR response in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

Description:

This is a multicenter extension study to both core Phase III studies CAIN457M2301 and CAIN457M2302 (Core studies). This study contains a randomized withdrawal design, double blinded and placebo controlled up to Week 104 or loss of response. The subjects with HiSCR response after 52 weeks of treatment in the "Core studies" will be randomized at 2:1 ratio to either continue on one of the two secukinumab dosing regimens assigned in "Core studies" for another 52 weeks or will be placed on placebo. The primary endpoint is loss of response (LOR) assessed during the 52-week treatment duration (up to Week 104). Subjects who attained LOR will be transferred to open-label treatment to continue until the end of the study. Subjects on placebo who did not reach LOR up to Week 104 will be offered to continue in the open-label treatment or discontinue the study. Thus for subjects who were HiSCR responders at Week 52 of "Core studies", the open label treatment duration will vary and start either from the time of LOR or from Week 104 dose and last until Week 260 followed by 8 weeks of a post treatment follow-up period to week 268. Subjects who were HiSCR non-responders at the end of "Core studies" will be offered to continue in open-label treatment until Week 260. Subjects who prematurely discontinue the study, or who complete the study will enter a post-treatment follow up period (8 weeks) The primary objective is to evaluate maintenance of HiSCR reponse at Week 104 in either continuous or interrupted therapy compared to placebo. Secondary objectives are to assess the long-term safety and tolerability evaluated by adverse events, abnormal laboratory values and vital signs.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 703
• Est. completion date: July 15, 2026
• Est. primary completion date: May 26, 2023
• 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
• subject must have completed the study treatment period (52 weeks) in the core studies (AIN457M2301 or AIN457M2302) and had received secukinumab treatment during Treatment Period 2

Exclusion Criteria:

• protocol deviation in the core study which will prevent the meaningful analysis of the extension study
• ongoing or planned use of prohibited HS or non-HS treatment
• participation in the extension could expose the subject to an undue safety risk
• current sever progressive or uncontrolled disease which renders the subject unsuitable for the study

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• secukinumab
secukinumab 300mg every 2 weeks
• secukinumab
secukinumab 300mg every 4 weeks

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Capital Federal
Argentina	Novartis Investigative Site	Ciudad Autonoma de Bs As	Buenos Aires
Argentina	Novartis Investigative Site	La Plata	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
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
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Liege
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Stara Zagora
Canada	Novartis Investigative Site	Barrie	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Peterborough	Ontario
Canada	Novartis Investigative Site	Waterloo	Ontario
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Croatia	Novartis Investigative Site	Zagreb	HRV
Czechia	Novartis Investigative Site	JIhlava
Czechia	Novartis Investigative Site	Plzen
Czechia	Novartis Investigative Site	Prague	Prague 1
Czechia	Novartis Investigative Site	Usti nad Labem	Czech Republic
France	Novartis Investigative Site	Antony
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Limoges	Haute Vienne
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Martigues
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris 10
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
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bielefeld
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Langenau
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Schwerin
Germany	Novartis Investigative Site	Wuerzburg
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki
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	Pecs
India	Novartis Investigative Site	Mysore	Karnataka
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	New Delhi	Delhi
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Petach Tikva
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	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pisa	PI
Italy	Novartis Investigative Site	Roma	RM
Japan	Novartis Investigative Site	Itabashi-ku	Tokyo
Japan	Novartis Investigative Site	Kisarazu	Chiba
Japan	Novartis Investigative Site	Koshigaya	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
Lebanon	Novartis Investigative Site	Saida
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Vilnius
Malaysia	Novartis Investigative Site	Johor Bahru
Malaysia	Novartis Investigative Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Novartis Investigative Site	Penang
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Netherlands	Novartis Investigative Site	Bergen op Zoom
Philippines	Novartis Investigative Site	Las Pinas
Philippines	Novartis Investigative Site	Makati City
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Ossy
Poland	Novartis Investigative Site	Rzeszow
Poland	Novartis Investigative Site	Warszawa
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	Porto
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	Yaroslavl
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Presov
South Africa	Novartis Investigative Site	Raslouw Centurion	Gauteng
South Africa	Novartis Investigative Site	Soweto	Gauteng
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Cadiz	Andalucia
Spain	Novartis Investigative Site	Fuenlabrada	Madrid
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
Spain	Novartis Investigative Site	Pontevedra
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Geneve
Switzerland	Novartis Investigative Site	Lausanne
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigative Site	Antalya
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Gaziantep
Turkey	Novartis Investigative Site	Istanbul	TUR
Turkey	Novartis Investigative Site	Talas / Kayseri
United Kingdom	Novartis Investigative Site	Barnsley
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Dudley	West Midlands
United Kingdom	Novartis Investigative Site	Exeter
United Kingdom	Novartis Investigative Site	Leeds	West Yorkshire
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Salford	Manchester
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Beth Israel Deaconess Medical Cente	Boston	Massachusetts
United States	Tufts Medical Center .	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Clinical Research Ctr of Carolinas	Charleston	South Carolina
United States	Florida Academic Centers Research and Education LLC	Coral Gables	Florida
United States	MDRI Baylor University	Dallas	Texas
United States	Wright State University	Fairborn	Ohio
United States	Northshore University Health System	Glenview	Illinois
United States	Dawes Fretzin Clinical Rea Group .	Indianapolis	Indiana
United States	University of MiamiHealth System .	Miami	Florida
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	Icahn School Of Med At Mount Sinai .	New York	New York
United States	Virginia Clinical Research .	Norfolk	Virginia
United States	Skin Specialists PC .	Omaha	Nebraska
United States	Austin Inst for Clinical Research	Pflugerville	Texas
United States	University of Pittsburgh Medical Center Health System	Pittsburgh	Pennsylvania
United States	Northwest Arkansas Center .	Rogers	Arkansas
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Saint Louis Univ Clinical Rea Unit 3rd Floor Dermatology	Saint Louis	Missouri
United States	Washington Uni School of Med .	Saint Louis	Missouri
United States	Dr. Stephen Miller, MDPA .	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	University Clinical Trials	San Diego	California
United States	Advanced Medical Research	Sandy Springs	Georgia
United States	Olympian Clinical Research Olympian Memorial HWY Pharmacy	Tampa	Florida
United States	University of South Florida .	Tampa	Florida
United States	Dundee Dermatology	West Dundee	Illinois
United States	Southern California Skin and Laser .	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,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  France,  Germany,  Greece,  Guatemala,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Malaysia,  Mexico,  Netherlands,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loss of response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) reponders	Loss of response was defined as: at least a 50% increase in abscess and/or nodules count (AN) compared to the average AN count from the 3 previous visits or at Week 52, whichever is lower and the increase was at least of 3 AN.; at least a 30% increase in AN compared to the average AN count from the 3 previous visits or Week 52, whichever is lower, with an increase of at least 2 AN and a further increase in the AN count of at least 2 AN at a re-assessment visit within 2-4 weeks.	Randomized Withdrawal Period (Randomization (Week 52) - LOR or up to Week 104)
Secondary	Number of Participants with Treatment Emergent Adverse Events	To assess the long-term safety and tolerability of secukinumab in subjects with moderate to severe HS	Weeks 52 - 268