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Trial details
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)
Current status:
Approved
|
Date registered:
15/04/2020
Trial version(s)
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
History: 08/02/2019
Current: 08/02/2019
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Main Information
Primary registry identifying number
LBCTR2019020191
Protocol number
CAIN457M2302
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
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)
Acronym
SUNRISE
Scientific 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)
Acronym
Brief summary of the study: English
The purpose of this study is 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 will also assess the safety and tolerability of secukinumab.
Brief summary of the study: Arabic
دراسة متعددة المراكز ومزدوجة التعمية وعشوائيّة التوزيع لتقييم الفعالي والسلامة وقدرة التحمّل القصيرة الأمد (16 أسبوعًا) والطويلة الأمد (لغاية سنة واحدة) لنظاميّ جرعات تحت الجلد من دواء سيكوكينوماب لدى مرضى بالغين مصابين بالتهاب الغدد العرقيّة القيحيّ (سانرايز SUNRISE)
Health conditions/problem studied: Specify
Patients with Hidradenitis Suppurativa
Interventions: Specify
Drug: Secukinumab Drug: Placebo
Key inclusion and exclusion criteria: 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.
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
•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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
Short (16 Weeks) and Long-term Efficacy (up to 1 Year), Safety, and Tolerability
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
Worldwide
Name of IMP
Secukinumab (Cosentyx)
Year of authorization
2016
Month of authorization
3
Type of IMP
Immunological
Pharmaceutical class
Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS and is thought to play a role in other inflammatory conditions.
Therapeutic indication
Patients with: Psoriasis (Pso) Ankylosing Spondylitis (AS) Psoriatic Arthritis (PsA)
Therapeutic benefit
Secukinumab has demonstrated positive benefit-risk in the treatment of multiple chronic inflammatory indications including moderate to severe plaque psoriasis, ankylosing spondylitis, psoriatic arthritis.
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples will be sent to Q Squared Solutions central Lab in UK as per study protocol to assess patient disease response following treatment administration.
Target sample size
8
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/04/2019
Date of study closure: Type
Anticipated
Date of study closure: Date
29/07/2022
Recruitment status
Pending
Date of completion
16/02/2021
IPD sharing statement plan
No
IPD sharing statement description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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://www.clinicaltrials.gov/ct2/show/NCT03713632?term=AIN457&recrs=ab&cond=Hidradenitis+Suppurativa&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
National Institute of Health (clinicaltrials.gov)
NCT03713632
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
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
Hammou Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Roy
Moutran
Beirut
Lebanon
9613592192
roymoutran@yahoo.com
Mount Lebanon Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Dr Hadi Hamam
Dermatology
Approved
Mount Lebanon Hospital
Dr Roy Moutran
Dermatology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
20/12/2018
Ahmad Zaatari
aatari@hammoudhospital.com
+961 (0) 7 723111 ext 1160
Mount Lebanon Hospital
30/04/2019
Marie Merheb
Marie.merheb@mlh.com.lb
+961 (0) 5 957 000 exr 1200
Countries of Recruitment
Name
Belgium
Argentina
Bulgaria
Croatia
Czech Republic
Brazil
Canada
Colombia
France
Denmark
Germany
Guatemala
India
Greece
Hungary
Lebanon
Malaysia
Italy
Turkey
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Hidradenitis Suppurativa
Hidradenitis suppurativa (L73.2)
Hidradenitis Suppurativa
Interventions
Intervention
Description
Keyword
Reference table 8-1 of the study protocol: Obtain informed consent (ICF), Demography, Inclusion / Exclusion criteria, Washout evaluation / instruction, Relevant medical history / current medical condition, HS medical history and previous therapies, Smoking history, Hurley stage, Prior / concomitant medications, Adverse Events, Physical Examination, Body Height, Body Weight, Vital Signs, Tuberculosis test, Lesion count (physician), Numerical Rating, Scale for pain assessment, Modified Hidradenitis Suppurativa Score (mHSS), HS-Physician's Global Assessment, Patient's Lesion Count, DLQI, EQ5D, Patient Global Impression of severity (PGI-s), Patient Global Impression of change (PGI-c), Work productivity Activity Impairment (WPAI)
ICF, Lab, questionnaires, Medication administration, physical examination
ICF, Lab tests, Questionnaires, Medication administration
Primary Outcomes
Name
Time points
Measure
Proportion of patients with Hidradenitis Suppurativa Clinical Response (HiSCR)
16 weeks
16 weeks
Key Secondary Outcomes
Name
Time points
Measure
Participants achieving NRS30
16 weeks
16 weeks
Proportion of patients with HS flares
16 weeks
16 weeks
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
new Import license submission
14/04/2020
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