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

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study
with two secukinumab dose regimens in approximately 471 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

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.