Study to Evaluate the Efficacy and Safety of 1.5 mg/kg/Day of Sarecycline vs Placebo in the Treatment of Acne Vulgaris

Treatment of inflammatory lesions of moderate to severe acne vulgaris in subjects 9 to 45
years of age with oral sarecycline 1.5 mg/kg/day compared to placebo in the subjects with
moderate to severe facial acne vulgaris based on Investigator's Global Assessment (IGA)
score and inflammatory lesion counts. Safety monitored and evaluated throughout 12-week
study.

Inclusion Criteria:

A subject will be considered for inclusion in the study if he/she meets all of the
following criteria:

- Is a male or female, 9 to 45 years of age, inclusive

- Has a body weight between 72 lb and 300 lb, inclusive

- Has facial acne vulgaris with:

- 20 to 50 inflammatory lesions (papules, pustules, and nodules)

- up to 100 noninflammatory lesions (open and closed comedones)

- No more than two nodules

- IGA score of moderate (3) or severe (4)

- Has a negative urine pregnancy test at baseline - females of childbearing potential
only

- Agrees to use an effective method of contraception throughout the study, if
applicable

- Refrain from use of any other acne medications and medicated cleansers, and avoid
excessive sun exposure and tanning booths for the duration of the study

- Is able to swallow the tablets

Exclusion Criteria:

A subject will be excluded from participation if he/she meets any of the following
criteria:

- Has a dermatological condition of the face (e.g., skin burn, sunburn, beard,
mustache) that could interfere with the clinical evaluations

- Has a history of any of the following:

- Allergy to tetracycline-class antibiotics or to any ingredient in the study drug

- Pseudomembranous colitis or antibiotic-associated colitis

- Treated for any type of cancer within the last 6 months

- Has known resistance to other tetracyclines

- Has received any of the following treatments within 12 weeks of randomization:

- Systemic retinoids

- Systemic corticosteroids

- Androgens/anti-androgenic therapy (e.g., anabolic steroids, spironolactone)

- Non-medicated procedures for the treatment of acne

- Has used any acne affecting treatment without an appropriate washout period

- Has initiated hormonal contraceptive use within 12 weeks prior to randomization or
plans to initiate or switch hormonal contraceptive products during the study period

- Is pregnant, lactating, or is planning a pregnancy during the study period

- Has any other disorder causing hyperandrogenism including, but not limited to,
polycystic ovary syndrome, adrenal or ovarian tumors, Cushing's disease, or
congenital adrenal hyperplasia

- Has drug-induced acne

- Has significant intercurrent illness, psychiatric disposition, or other factors that,
in the opinion of the Investigator or Medical Monitor, precludes participation in the
study

- Is currently participating, or has participated within 30 days prior to the
randomization period, in an investigational drug or device study

- Has previously participated in any clinical trial involving the use of sarecycline

- Is judged by the Investigator to be unsuitable for any reason