NCT06775860招募中3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 552
- 试验地点
- 62
- 主要终点
- Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
研究概览
简要总结
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between 18 and 75 years of age.
- •Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- •Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- •Subjects must meet the following criteria for disease activity:
- •Eczema Area and Severity Index (EASI) score ≥ 16 ;
- •(Body Surface Area )BSA affected by AD ≥ 10% ;
- •(validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
- •Baseline weekly average of daily Worst Pruritus NRS ≥
- •Women of childbearing potential (WOCBP) and Men must agree
- •5. Women of childbearing potential (WOCBP) and Men must agree to contraception.
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- •Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- •Pregnant or breastfeeding females.
- •History of any clinically major diseases, with the exception of atopic dermatitis.
- •Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
研究组 & 干预措施
ICP-332
Experimental
干预措施: ICP-332 Tablets (Drug)
Placebo
Placebo Comparator
干预措施: ICP-332 Placebo Tablets (Drug)
结局指标
主要结局
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
时间窗: 16 weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (62)
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