Clinical trial NCT04179175: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hidradenitis Suppurativa
Keywords: acne inversa
Hidradenitis suppurativa (HS)
maladie de Verneuil
inflammatory disease
AIN457
AIN457M
Secukinumab
Loss of Response (LOR)
Hidradenitis Suppurativa Clinical Response (HiSCR)
interleukin-17A (IL-17A)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 703
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, double-blind, randomized withdrawal extension, parallel group study followed by an open-label, active-treatment period with two Secukinumab dose regimens in approximately 856 patients with moderate to severe hidradenitis suppurativa (HS)
Primary purpose: TREATMENT

Brief summary: The purpose of this extension study is to evaluate maintenance of Hidradenitis Suppurativa Clinical Response (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 CAIN457M2301 (NCT03713619) and CAIN457M2302 (NCT03713619).

Detailed 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 response 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
timeFrame: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.
measure: Incidence Rate of Participants Achieving Loss of Response (LOR) up to Week 104 in Hidradenitis Suppurativa Clinical Response (HiSCR) Responders
timeFrame: Up to 52 weeks: from randomization at the extension study (Week 52) up to Week 104 or loss of response. Study day is defined with respect to the core studies.
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: Up to 216 weeks: from randomization at the extension study (Week 52) up to Week 268. Study day is defined with respect to the core studies.
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Northwest Arkansas Center
state: Arkansas
city: San Diego
country: United States
facility: MedDerm Associates
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Whittier
country: United States
facility: Southern California Skin and Laser
state: California
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education LLC
state: Florida
city: Miami
country: United States
facility: University of MiamiHealth System
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Glenview
country: United States
facility: Endeavor Health
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Rea Group
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Cente
state: Massachusetts
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Clinical Research Unit
state: Missouri
city: Saint Louis
country: United States
facility: WA Uni School Of Med
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: New York
country: United States
facility: Icahn School Of Med At Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Fairborn
country: United States
facility: Wright State University
state: Ohio
city: Pittsburgh
country: United States
facility: UP Medical Center H System
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Ctr of Carolinas
state: South Carolina
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: MDRI Baylor University
state: Texas
city: Pflugerville
country: United States
facility: Austin Inst for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Dr. Stephen Miller, MDPA
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Caba
country: Argentina
facility: Novartis Investigative Site
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city: Ciudad Autonoma de Bs As
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facility: Novartis Investigative Site
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city: La Plata
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city: Buenos Aires
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city: Prague
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city: Antony
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city: Paris 10
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city: Rouen
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city: Saint Mande
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city: St-Priest-en-Jarez
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facility: Novartis Investigative Site
city: Toulouse
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city: Langenau
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state: Baden-Wuerttemberg
city: Halle Saale
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state: Sachsen-Anhalt
city: Berlin
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facility: Novartis Investigative Site
city: Bielefeld
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facility: Novartis Investigative Site
city: Bochum
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city: Frankfurt
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city: Hamburg
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city: Memmingen
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city: Muenchen
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city: Muenster
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city: Potsdam
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city: Wuerzburg
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city: Chaidari
country: Greece
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state: Attiki
city: Thessaloniki
country: Greece
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state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Guatemala City
country: Guatemala
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city: Guatemala City
country: Guatemala
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city: Debrecen
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city: Pecs
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state: Delhi
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state: Karnataka
city: Nagpur
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state: Maharashtra
city: Nashik
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state: Maharashtra
city: Jerusalem
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city: Petach Tikva
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city: Ramat Gan
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city: Tel Aviv
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city: Ancona
country: Italy
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state: AN
city: Cona
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state: FE
city: Firenze
country: Italy
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state: FI
city: Milano
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state: MI
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state: PI
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state: RM
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state: Chiba
city: Ginowan
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state: Okinawa
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state: Saitama
city: Itabashi-ku
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state: Tokyo
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city: Seoul
country: Korea, Republic of
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city: Seoul
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city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Saida
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city: Vilnius
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country: Malaysia
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city: Saint Petersburg
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city: Saint Petersburg
country: Russian Federation
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city: Smolensk
country: Russian Federation
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city: Yaroslavl
country: Russian Federation
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city: Singapore
country: Singapore
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city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
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city: Presov
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facility: Novartis Investigative Site
city: Raslouw Centurion
country: South Africa
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state: Gauteng
city: Soweto
country: South Africa
facility: Novartis Investigative Site
state: Gauteng
city: Cadiz
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Granada
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Fuenlabrada
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Manises
country: Spain
facility: Novartis Investigative Site
state: Valencia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Geneve 14
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
state: TUR
city: Antalya
country: Turkey
facility: Novartis Investigative Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Gaziantep
country: Turkey
facility: Novartis Investigative Site
city: Pendik Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Talas Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Exeter
country: United Kingdom
facility: Novartis Investigative Site
state: Devon
city: Dudley
country: United Kingdom
facility: Novartis Investigative Site
state: West Midlands
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Barnsley
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Salford
country: United Kingdom
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: