2023-504539-42-00招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Abrocitinib in Subjects with Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Percent change from baseline in hand mTLSS at Week 16
研究概览
简要总结
To evaluate the efficacy of abrocitinib in subjects with moderate to severe CHE
研究设计
- 分配方式
- Randomized
- 主要目的
- Part A and Part B
- 盲法
- Double (Subject, Carer, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult subject, 18 years of age or older, at the time of consent.
- •Subject has a history of moderate to severe CHE for at least 6 months prior to Day
- •Subject has refractory hand eczema.
- •Subject has moderate to severe CHE at screening and Day 1, as defined by a hand PGA of 3 or
- •Contraceptive use by women of childbearing potential or their male partners during the study and until ≥ 4 weeks after the last study product administration.
排除标准
- •Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
- •Subject has a history or has current active psoriasis.
- •Subject has a history of eczema herpeticum within 12 months prior to screening, and/or a history of 2 or more episodes of eczema herpeticum in the past.
- •Subject has any clinically significant medical condition (including psychiatric condition) or physical/laboratory/vital signs abnormality.
- •Subject has known or suspected allergic contact dermatitis of the hands and is unable to avoid exposure to the causative allergen or subjects with suspected or expected changes in irritant or allergen exposures from screening through the end of the study
结局指标
主要结局
Percent change from baseline in hand mTLSS at Week 16
Percent change from baseline in hand mTLSS at Week 16
次要结局
- Proportion of subjects achieving at least a 2-grade reduction from baseline in hand PGA at Weeks 2, 4, 12, and 16
- Percent change from baseline in HESCI at Weeks 2, 4, 12, and 16
- Percent change from baseline in hand mTLSS at Weeks 2, 4, and 12
- Proportion of subjects achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in hand PGA at Weeks 2, 4, 12, and 16
- Percent change from baseline in Extent of Disease affected with moderate to severe CHE at Weeks 2, 4, 12 and 16.
- Actual PaGA measeruments at Weeks 2, 4, 12 and 16
- Percent change from baseline in hand DLQI at Weeks 2, 4, 12 and 16
- Percent change from baseline in QOLHEQ at Weeks 2, 4, 12 and 16
- Percent change from baseline in pain NRS at Weeks 2, 4, 12 and 16
- Percent change from baseline in itch NRS at Weeks 2, 4, 12 and 16
- Number of TEAEs
- Number of treatment-related TEAEs
- Vital signs and safety laboratory tests
研究者
Scientific Affairs Department
Scientific
Innovaderm Research Inc.
研究点 (10)
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