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Trial details
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
Current status:
Approved
|
Date registered:
29/05/2021
Trial version(s)
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
History: 29/12/2020
Current: 29/12/2020
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Main Information
Primary registry identifying number
LBCTR2020124720
Protocol number
CAIN457M2301E1
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
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
Acronym
Scientific title
CAIN457M2301E1 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
Acronym
Brief summary of the study: English
The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 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).
Brief summary of the study: Arabic
دراسة تمديد وانسحاب متعددة المراكز ومزدوجة التعمية وعشوائيّة التوزيع حول سيكوكينوماب تحت الجلد لإثبات الفعالية والسلامة والتحمّل على المدى الطويل لدى مرضى مصابين بالتهاب الغدد العرقيّة القيحيّ المتوسّط إلى الشديد الحدّة
Health conditions/problem studied: Specify
Hidradenitis Suppurativa
Interventions: Specify
Drug: secukinumab
Key inclusion and exclusion 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 have been receiving secukinumab treatment during Treatment Period 2
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
US, Australia, UK, Belgium, Canada,France, Germany, Poland, Bulgaria, Greece, India, Spain, Taiwan, Turkey
Name of IMP
Secukinumab (Cosentyx)
Year of authorization
2016
Month of authorization
3
Type of IMP
Immunological
Pharmaceutical class
selective for human IL-17A
Therapeutic indication
Patients with: - Psoriasis (Pso) - Ankylosing Spondylitis (AS) - Psoriatic Arthritis (PsA)
Therapeutic benefit
time to loss of response (LOR) in HiSCR reponders
Biospecimen retention
Samples without DNA
Biospecimen description
Blood samples collected will be analyzed at Q2 Solutions, central lab
Target sample size
3
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
05/02/2021
Date of study closure: Type
Anticipated
Date of study closure: Date
29/12/2026
Recruitment status
Pending
Date of completion
30/06/2022
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04179175?term=CAIN457M2301E1&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical trials.gov
NCT04179175
Sources of Monetary or Material Support
Name
Novartis Pharma Services
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hadi
Hamam
Saida
Lebanon
9613795246
hadihamam@hotmail.com
Hammoud Hospital University Medical Center
Scientific
Hind
Khairallh
Sinelfil
Lebanon
01512002#271
Hind.khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Hadi Hamam
Dermatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
02/11/2020
Ahmad Zaatari
zaatari@hammoudhospital.com
961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Lebanon
Australia
Austria
Belgium
Bulgaria
Canada
Czech Republic
France
Germany
Greece
Hungary
India
Italy
Japan
Republic of Korea
Lithuania
Malaysia
Poland
Portugal
Russian Federation
Singapore
Slovakia
South Africa
Spain
Switzerland
Taiwan
Turkey
United Kingdom
United States of America
Viet Nam
Health Conditions or Problems Studied
Condition
Code
Keyword
Hidradenitis Suppurativa
Skin, unspecified (D23.9)
Hidradenitis Suppurativa
Interventions
Intervention
Description
Keyword
Informed Consent form discussion; Inclusion/exclusion assessment; physical examination; blood samples collection; questionnaires review and assessment; IMP dispensation
Informed Consent form discussion; Inclusion/exclusion assessment; physical examination; blood samples collection; questionnaires review and assessment; IMP dispensation
Informed Consent form discussion; Inclusion/exclusion assessment; physical examination; blood samples collection; questionnaires review and assessment; IMP dispensation
Primary Outcomes
Name
Time points
Measure
time to loss of response (LOR) in HiSCR reponders
Weeks 52-104
Weeks 52-104
Key Secondary Outcomes
Name
Time points
Measure
Cumulative rate of subjects who experience a flare in core HiScr responders
Week 104
Week 104
subjects achieving NRS30
Week 104
Week 104
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
SUSARS Oct 20-Mar 21
26/05/2021
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