CTIS2022-502853-32-00招募中1 期
A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients with Netherton Syndrome - DS2325-119
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
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 64（—）
- 性别
- All
入选标准
- •Male or female patients aged 18 to 65 years with clinical diagnosis of NS including at least 3 out of the 4 following clinical criteria: 1. Neonatal erythroderma; 2. Bamboo hair and/or alopecia; 3. Chronic atopy specified as food allergy and/or asthma and/or rhino-conjunctivitis and/or eczema for at least 2 years; 4. Ichthyosis linearis circumflexa or scaling erythroderma or equivalent. Eligible participants are those who have received treatment in the past that did not work and so need the further care., Immunohistochemistry documentation of absence of lympho-epithelial Kazal-type-related inhibitor (LEKTI) in the skin or confirmed serine peptidase inhibitor of Kazal type 5 (SPINK5) gene mutations., NS involvement of =20% of Body Surface Area (BSA) at both Screening and Baseline., Patients must give written informed consent to participation in the study prior to Screening., Patients must be willing to have skin tape harvests collected from lesional and non-lesional skin areas
排除标准
- •Any skin disease that may interfere with the diagnosis or evaluation of NS., Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before Screening visit.
研究者
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