Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa

Secukinumab is an antibody that inhibits Interleukin-17A, and IL-17 promotes neutrophil
activities. Neutrophils are found in large numbers in HS. The expression of the inflammatory
cytokines IL-17, IL-1β, and TNF-α were enhanced in lesional skin of HS patients.

Prior studies have demonstrated improvement in HS with biologic medications such as the tumor
necrosis factor inhibitors adalimumab and infliximab. Studies have shown conflicting data
regarding the efficacy of etanercept for HS and success with anakinra.

This is an initial pilot study of secukinumab for the purpose of studying how it may alter HS
disease symptoms. This study is not intended to alter indications for drug use but may inform
the design of an efficacy study that may alter FDA labeling changes in the future. There are
limitations of this study that arise from it being a single-arm clinical trial with a small
number of subjects. These limitations include the limited generalizability knowledge of this
study due to the lack of an active comparator. However, the data obtained from this study
will potentially be used to support the design of larger future randomized placebo controlled
studies.

Inclusion Criteria:

- Patients must give written informed consent before any assessment is performed.

- Subject has moderate-to-severe HS as defined by: 1. HS lesions in at least 2 distinct
anatomic areas, one of which is Hurley stage II or III on evaluation at Screening. 2.
Stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline
visit as determined by the investigator.

- Total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the
Baseline visit.

- Subject has had HS diagnosis for at least 3 months prior to Baseline.

- Subject must have failed at least one prior course of oral antibiotics.

- Subject must agree to daily use (and throughout the entirety of the study) of one of
the following over-the-counter topical antiseptics on their body areas affected with
HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in
bathwater.

- Subject must be at least 18 years of age at time of Screening

Exclusion Criteria:

- Subject has had history of malignancy within the past 5 years

- Women who are pregnant, nursing, or planning pregnancy within 6 months after last
subcutaneous injection. Male patients who are planning for their partner's pregnancies
within 6 months from the last subcutaneous injection

- Subject has history of active TB. Subjects with latent TB must have been on treatment
for at least 8 weeks prior to Baseline visit and the course of prophylaxis is planned
to be completed.

- Subject has had infections requiring oral or intravenous (IV) antibiotics within 14
days prior to Baseline.

- Subject has significant serious medical problems or a condition that significantly
immunocompromises the subject.

- Subject has had clinically significant hematological abnormalities defined as HGB
<13.5 g/dL (<135 g/L) or a HCT <41.0 percent in men, or a value <12.0 g/dL (<120 g/L)
or <36.0 percent in women.

- Subject has previously used secukinumab.

- Subject has had any other active skin disease or condition that may interfere with HS
assessment.

- Subject has received prescription topical therapies for treatment of HS within 7 days
prior to Baseline.

- Subject has received systemic non-biologic therapies with potential therapeutic impact
for HS <14 days prior to Baseline visit.

- Clinically significant abnormal laboratory values as evaluated by the investigator.

- Patients with Crohn's disease or Ulcerative Colitis.

- Subject has received any systemic immunosuppressive treatment within 1 month prior to
Baseline visit. Subject has received anti-TNF therapy within 3 months prior to
Baseline visit. Subject has received anti IL-23 therapy within 3 months prior to
Baseline visit.

- Subject has received intralesional steroid injection within 2 weeks prior to Baseline
visit.

- Subject with known Human Immunodeficiency Virus (HIV) positive status or with positive
HIV testing at Screening.

- Subjects with Hepatitis B and Hepatitis C positive status or with positive Hepatitis B
and Hepatitis C testing at screening.

- Subjects with active cardiovascular disease or relevant risk factors such as prior
myocardial infection or stroke.

- Subjects with chronic infection or a history of recurrent infections.

- Subjects with a history of latex allergy or sensitivity.