Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

A Randomized, Multicenter, Double-blind, Placebocontrolled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris

To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Inclusion Criteria:

• Signed informed consent or assent form
• Male/female, 9 to 45 years of age, inclusive
• Body weight between 33 and 136 kg, inclusive
• Facial acne vulgaris with:
• 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
• No more than 2 nodules
• IGA score of moderate (3) or severe (4)
• Negative urine pregnancy test at baseline - females of childbearing potential
• Agrees to use an effective method of contraception throughout the study
• Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
• Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)

Exclusion Criteria:

• Has a dermatological condition of the face 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 screening:
• Systemic retinoids
• Systemic corticosteroids
• Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
• Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
• Has used any acne affecting treatment without an appropriate washout period
• Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
• Is pregnant, lactating or 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, Cushings 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 screening 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