A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate Safety and Efficacy of ASC40 (Denifanstat) Tablets in Subjects With Moderate to Severe Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 41
- 主要终点
- Percentage of treatment success based on investigator's global assessment (IGA) in each group of subjects
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of ASC40 (Denifanstat) tablets compared to placebo in the treatment of patients with moderate to severe acne vulgaris. The proposed plan for this trial is to enroll subjects who are 18-40 years of age (including borderline values), with a diagnosis of moderate to severe acne vulgaris, and an Investigator's Global Assessment (IGA) graded as moderate (grade 3) or severe (grade 4). 480 subjects were planned to be enrolled in the trial and placebo groups, with all subjects randomly assigned in a 1:1 ratio to receive either ASC40 (denifanstat) tablets dose 1 or placebo, administered orally once daily (taken after dinner) for 12 weeks.
There will be a total of 6 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-40 years (inclusive of threshold), gender is not limited.
- •Subjects have an Investigator's Global Assessment (IGA) score of 3 or 4 (i.e., moderate or severe).
- •Men of childbearing potential and women of childbearing potential willing to use effective contraception from the time of signing the informed consent until 3 months after the last dose of the investigational drug; women of childbearing potential include premenopausal women and women within 2 years of menopause. Women of childbearing potential must have a negative pregnancy test result within ≤ 7 days prior to the first dose of the investigational drug.
- •Subjects are willing and able to complete the study, are able to understand and comply with the study requirements, adhere to the study required restrictions and related tutorials, use the investigational drug as prescribed, and are followed up according to the study plan.
排除标准
- •Known hypersensitivity to the ingredients of ASC40 (Denifanstat) tablets or to any of the excipients.
- •Presence of cystic acne at screening.
- •Patients with secondary acne such as occupational acne (e.g., chloracne) and corticosteroid-induced secondary acne (e.g., chloracne or drug-induced acne)
- •Patients with other significant coexisting skin conditions that may affect the evaluation of facial acne efficacy or require co-treatment, such as solardermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema, etc..
- •Thicker facial hair, which has been assessed by researchers to impede accurate assessment of acne vulgaris grades or lesion counts
研究组 & 干预措施
ASC40 Placebo
ASC40 Placebo 84 days of treatment
干预措施: ASC40 (Drug)
ASC40 dose 1
ASC40 dose 1 84 days of treatment
干预措施: ASC40 (Drug)
结局指标
主要结局
Percentage of treatment success based on investigator's global assessment (IGA) in each group of subjects
时间窗: At Week 12 of treatment.
Percentage of treatment success subjects in each group based on investigator's global assessment (IGA) at Week 12 (treatment success defined as an IGA grade of 0 or 1, and a ≥2-grade decrease in IGA grade from baseline)
Percentage change in total skin lesion counts compared to baseline ineach group of subjects
时间窗: At Week 12 of treatment.
Percentage change in total skin lesion counts compared to baseline for subjects in each group at Week 12
Percentage change in the count of inflammatory skin lesions compared to baseline in each group of subjects
时间窗: At Week 12 of treatment.
Percentage change in inflammatory skin lesion counts compared to baseline for subjects in each group at Week 12
次要结局
- Percentage change in non-inflammatory lesion counts compared to baseline for each group of subjects(At Week 12 of treatment.)
- Absolute change in inflammatory skin lesion counts compared to baseline in each group of subjects(At Week 12 of treatment.)
- Absolute change in total skin lesion counts compared to baseline for each group of subjects(At Week 12 of treatment.)