A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris

Almirall

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Sarecycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02413346

SC1403

Details and patient eligibility

About

Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral sarecycline in the long-term treatment of participants with moderate to severe facial acne vulgaris.

Enrollment: 490 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully completed participation in Phase 3 study of sarecycline (SC1401 or SC1402)
• Signed informed consent or assent form
• Body weight between 33 kg and 136 kg, inclusive
• Negative urine pregnancy test for females of childbearing potential
• Agrees to use effective method of contraception throughout study, if applicable.
• Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)

Exclusion criteria

• Currently participating in another clinical study, unless it is a pharmacokinetic sarecycline study and participation approved by medical monitor; has received investigational medication (except sarecycline) within 30 days of enrollment.
• Discontinued participation in a Phase 3 study with sarecycline for any reason
• Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
• Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
• Is pregnant, lactating or planning a pregnancy during the study period
• Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
• Is judged by the Investigator to be unsuitable for any reason

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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490 participants in 2 patient groups

Placebo/Sarecycline

Experimental group

Description:

Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).

Treatment:

Drug: Sarecycline

Sarecycline/Sarecycline

Experimental group

Description:

Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).

Treatment:

Drug: Sarecycline