This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS. The study consists of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there will be an optional extension study. Adult males and females with moderate to severe HS will be included, with a diagnosis of HS greater than 1 year prior to baseline. Dosing will be once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included. The primary objective is to demonstrate the efficacy of secukinumab compared to placebo with respect to HISCR after 16 weeks of treatment; primary secondary objectives are to assess difference in proportion of patients with HS flares, and proportion of patients with clinical response in HS related skin pain after 16 weeks of treatment. Key safety data will be collected, along with Patient Reported Outcomes.

Official Title
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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).

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Drug: secukinumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, double-blind, placebo-controlled, parallel group study, with two secukinumab dose regimens in approximately 541 patients with moderate to severe HS
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: secukinumab 1<br>Secukinumab 300mg every 2 weeks | Drug: secukinumab<br>* Secukinumab 300mg every 2 or every 4 weeks<br>* Other names: AIN457;|
| Active Comparator: secukinumab 2<br>Secukinumab 300mg every 4 weeks | Drug: secukinumab<br>* Secukinumab 300mg every 2 or every 4 weeks<br>* Other names: AIN457;|
| Placebo Comparator: placebo 1<br>Placebo group to secukinumab 300mg every 2 weeks | Drug: Placebo<br>* Placebo 300mg every 2 or every 4 weeks<br>|
| Placebo Comparator: placebo 2<br>Placebo group to secukinumab 300mg every 4 weeks | Drug: Placebo<br>* Placebo 300mg every 2 or every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and/or in the number of draining fistulae. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Hidradenitis Suppurativa (HS) flares | Patients who experience at least one flare over 16 weeks, flare defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline | 16 weeks | 
| Participants achieving NRS30 | HS-related skin pain Patients achieving Numerical Rating Scale score of 30 (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 (where range 0 [no skin pain] to 10 [worst skin pain]) | 16 weeks | 
| Percentage change in AN count | Percent change in abscesses and inflammatory nodules (AN) count | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne inversa, Hidradenitis suppurativa, maladie de Verneuil, inflammatory disease, AIN457, AIN457M, secukinumab