EUCTR2018-004409-17-NL进行中（未招募）1 期
An Open-label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects with Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants with total body weight of 10 kg or higher at Baseline
- •Participants diagnosed with active severe atopic dermatitis (AD) defined by the Eczema Area Severity Index (EASI), Investigator’s Global Assessment (IGA) and body surface area (BSA)
- •Candidate for systemic therapy or have recently required systemic therapy for atopic dermatitis
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 32
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior exposure to Janus Kinase (JAK) inhibitor
- •Requirement of prohibited medications during the study
- •Systemic use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 1 month of the first dose of study drug and through the end of the study
研究者
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