NCT07749716招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Subjects With Severe Alopecia Areata
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Proportion of subjects with a Severity of Alopecia Tool (SALT) score ≤ 20
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of VC005 tablets in subjects with severe alopecia areata (AA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fully understand the study, be willing and able to comply with all trial procedures, voluntarily participate in the clinical trial, and provide written informed consent by signing the informed consent form (ICF).
- •Subjects must be aged between 18 and 65 years (inclusive) at the time of ICF signing, regardless of gender.
- •Subjects must meet the diagnostic criteria for alopecia areata (AA) at both screening and baseline visits.
排除标准
- •Women who are pregnant or breastfeeding, or subjects who plan to become pregnant or breastfeed during the study period.
- •Subjects with a current diagnosis of acute diffuse alopecia areata (AA).
- •Subjects with a current diagnosis of other types of alopecia that may interfere with the evaluation of AA, including but not limited to traction alopecia, cicatricial alopecia, telogen effluvium, androgenetic alopecia, syphilitic alopecia, anagen effluvium, folliculotropic mycosis fungoides, or alopecia caused by thyroid disease, etc.
- •Subjects with other scalp diseases that may affect the assessment of AA, such as scalp psoriasis, dermatitis, tinea capitis, etc.
研究组 & 干预措施
VC005 Tablets Low Dose group
Experimental
干预措施: Drug: VC005 tablets (Drug)
VC005 Tablets High Dose group
Experimental
干预措施: VC005 tablets (Drug)
VC005 Tablets placebo group
Placebo Comparator
干预措施: VC005 placebo tablets (Drug)
结局指标
主要结局
Proportion of subjects with a Severity of Alopecia Tool (SALT) score ≤ 20
时间窗: at Week 24 (W24)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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