CTIS2023-504539-42-00进行中(未招募)1 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 - INNO-6052
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+(—)
- 性别
- All
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 1., 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 4., Contraceptive use by women of childbearing potential or their male partners during the study and until = 4 weeks after the last study product administration should be consistent with local availability/regulations regarding the use of contraceptive methods for those participating in clinical trials.
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 that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results., 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
研究者
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