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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03713619




Registration number
NCT03713619
Ethics application status
Date submitted
18/10/2018
Date registered
22/10/2018
Date last updated
17/07/2019

Titles & IDs
Public title
This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).
Scientific title
A Randomized, Double-blind, Multi-center 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 (SUNSHINE).
Secondary ID [1] 0 0
CAIN457M2301
Universal Trial Number (UTN)
Trial acronym
SUNSHINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - secukinumab

Active Comparator: secukinumab 1 - Secukinumab 300mg every 2 weeks

Active Comparator: secukinumab 2 - Secukinumab 300mg every 4 weeks

Placebo Comparator: placebo 1 - Placebo group to secukinumab 300mg every 2 weeks

Placebo Comparator: placebo 2 - Placebo group to secukinumab 300mg every 4 weeks


Treatment: Drugs: secukinumab
Secukinumab 300mg every 2 or every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Hidradenitis Suppurativa clinical response (HiSCR) - HiSCR is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses or in the number of draining fistulae.
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
proportion of patients with HS flares - Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Participants achieving NRS30 - HS-related skin pain Patients achieving 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
Timepoint [2] 0 0
16 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Phillip
Recruitment hospital [2] 0 0
Novartis Investigative Site - Benowa
Recruitment hospital [3] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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North Carolina
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Linz
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Bruxelles
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Prague 1
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Kosice
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Martin
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Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03713619
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
novartis.email@novartis.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03713619