Single Center Study of Apremilast for the Treatment of Hidradenitis Suppurativa

This study is an open-label 28-week trial. All Subjects will receive Apremilast with the
initial titrating dose as per package insert (10mg per day on day #1, escalating to 30mg
twice daily at day #6 and continuation at this dose).

The primary efficacy endpoint is:

The Proportion of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at
week 16, defined as a 30% reduction in the total number of abscess and inflammatory nodule
count with a 50% reduction as an exploratory endpoint..

The Secondary endpoints are:

1. The number of patients achieving a one point reduction in the Physician's Global
Assessment (PGA) score at week 16

2. Changes in Modified Sartorius scale from Baseline to Week 16

3. The number of patients achieving a two point reduction (required from baseline score) in
the Visual Analog Scale (VAS) pain score at week 16

4. Dermatology Life Quality Index or DLQI,

The study will be conducted over 24 weeks on active therapy followed by a four week
observational visit. The total length of the study will be 28 weeks.

Study visits will occur at Baseline (Week 0), Weeks 4, 8, 12, 16, 20, 24, and then a
observational follow up 4 weeks afterwards. Additionally, all subjects will be contacted by
phone 1 week following the Baseline visit to ensure daily pain assessments are being
recorded. If any signs or symptoms are reported at the time of the call, an unscheduled study
visit will be conducted to assess whether an infection is present.

Adverse events will be collected throughout the study.

Inclusion Criteria:• Have the capacity to understand and sign and Informed Consent Form.

- Subject must be in general good health ( except for Hidradenitis Suppurativa) as
judged by the Investigator, based on medical history, physical examination, clinical
laboratories and urinalysis. NOTE: the definition of good health means a subjects that
does not have uncontrolled significant co-morbid conditions.

- Must have a diagnosis of Hidradenitis Suppurativa (HS) for at least 6 months prior to
Baseline/Screening visit

- Subjects with moderate Hidradenitis Suppurativa (HS) with a Physician's Global
Assessment (PGA) score of 3 defined as having: 0 abscesses, 0 draining fistula, and 5
inflammatory nodules; or 1 abscess or draining fistula and 1 inflammatory nodule; or
2-5 abscesses or draining fistulas and 10 inflammatory nodules

- Hidradenitis Suppurativa (HS) lesions must be present in at least two distinct
anatomic areas, one of which must be at least Hurley Stage II (see definition of
terms)

- Subject must have stable HS for at least 2 months (60 days) prior to Screening/
Baseline visit as determined by the investigator through subject interview and review
of medical history;

- Subject must have a total abscess and inflammatory nodule (AN) count (PGA) of no
greater than moderate at the Baseline visit. Patient with PGA 0-1 (No disease or
minimal Disease will be excluded).

- 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 Hidradenitis Suppurativa
(HS) lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach
in bathwater.

- Women who are postmenopausal must have a negative serum pregnancy test on entry in the
study.

- Females of childbearing potential (FCBP)† must have a negative pregnancy test at
Screening and Baseline. While on investigational product and for at least 28 days
after taking the last dose of investigational product, FCBP who engage in activity in
which conception is possible must use one of the approved contraceptive§ options
described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral,
injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal
ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS
one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with
spermicide; or (c) contraceptive sponge with spermicide.

- Male subjects (including those who have had a vasectomy) who engage in activity in
which conception is possible must use barrier contraception (male latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane])
while on investigational product and for at least 28 days after the last dose of
investigational product.

† A female of childbearing potential is a sexually mature female who 1) has not
undergone a hysterectomy (the surgical removal of the uterus) or bilateral
oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal
for at least 24 consecutive months (that is, has had menses at any time during the
preceding 24 consecutive months).

§ The female subject's chosen form of contraception must be effective by the time the
female subject is randomized into the study (for example, hormonal contraception
should be initiated at least 28 days before randomization).

- The screening/baseline laboratory test results must meet the following criteria (WNL
means within normal limits for patients with HS [e.g., may have slightly higher WBC
and platelet counts]):

- WBC (white blood cell count): WNL

- ANC (absolute neutrophil count): WNL

- Hemoglobin: >10 mg/dl

- Platelets: WNL

- Serum Creatinine: WNL

- SGOT (AST - aspartate aminotransferase): <2 times upper normal limit

- SGPT (ALT - alanine aminotransferase): <2 times upper normal limit

- Alkaline phosphatase:<2 times upper normal limit

Exclusion Criteria:

- The presence of any of the following will exclude a subject from enrollment:

- Subjects with PGA 4 and 5 , with 15 lesions and significant scarring (defined as any
linear, indurated area, extended across more than 50% of the circumference of the
affected area) ,fistulas or sinus tract involvement will be excluded.

- Other than Hidradenitis Suppurativa , any clinically significant (as determined by the
Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,
renal, hematologic, immunologic disease, or other major disease that is currently
uncontrolled.

- Any condition, including the presence of laboratory abnormalities, which would place
the subject at unacceptable risk if he/she were to participate in the study.

- Prior history of suicide attempt at any time in the subject's life time prior to
screening or randomization, or major psychiatric illness requiring hospitalization
within the last 3 years.

- Women who are pregnant, nursing, or planning pregnancy within 6 months after the last
study drug dose (this includes father's who plan on fathering a child within 6 months
after their last study drug dose.

- Active substance abuse or a history of substance abuse within 6 months prior to
Screening

- Malignancy or history of malignancy, except for:

- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of
cervix with no evidence of recurrence within the previous 5 years.

- Active substance abuse or a history of substance abuse within 6 months prior to
Screening. .

- Patient with diagnosis or suspected Crohns disease

- Patient who is on a stable dose of analgesics, will be allowed to remain on them. No
new opiates will be permitted during the trial.

- Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmocokinetic/pharmacodynamic half-lives, if known (whichever is longer).

- Prior treatment with Apremilast

- Known allergy to Apremilast

- Have a known history of serious infections (eg, hepatitis, pneumonia or
pyelonephritis) in the previous 3 months

- Have a history of lymphoproliferative disease, including lymphoma or signs suggestive
of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
location (eg, nodes in the posterior triangle of the neck, infraclavicular,
epitrochlear, or periaortic area), or splenomegaly

- Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral
disease.

- Are unable or unwilling to undergo multiple venipunctures because of poor tolerability
or lack of easy access

- Patient with significant scarring, fistulas, or sinus tract involvement will be
excluded. Only subjects with inflammatory abscesses and nodules will be allowed to
enter the study.

- Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics,
antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives
(antibiotics, antivirals, antifungals) within 14 days prior to Baseline

- Any other active skin disease or condition (e.g., bacterial, fungal or viral
infection) that may interfere with assessment of HS;

- History of invasive infection (e.g., listeriosis, histoplasmosis), human
immunodeficiency virus (HIV);

- Subject has an active systemic viral infection or any active viral infection that
based on the investigator's clinical assessment make the subject an unsuitable
candidate for the study;

- Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative
test for HBc Ab/HBsAb positive subjects; Or Hepatitis C

- Chronic recurring infections or active TB;

- Evidence of dysplasia

- Pregnant (or considering becoming pregnant) or lactating females.

- The use of any prior biologic therapy is prohibited

- Subjects currently undergoing any of the following treatments for HS will require a 2
week wash-out period: Minocycline; Tetracycline; Clindamycin; Rifampicin and Steroids.