A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 55
- 主要终点
- Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo/Sarecycline
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).
干预措施: Sarecycline (Drug)
Sarecycline/Sarecycline
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).
干预措施: Sarecycline (Drug)
结局指标
主要结局
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
时间窗: Up to 40 Weeks
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.
次要结局
未报告次要终点