jRCT2031250138尚未招募不适用
Phase 3 Clinical Study of JTE-061 Cream - 52-week Long-term Study in Infant Patients with Atopic Dermatitis -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 3month old over 至 24month old not（—）
- 性别
- All
入选标准
- •Japanese patients aged 3 months to < 24 months at informed consent who can visit the study site as an outpatient
- •Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
- •Patients whose IGA score, EASI score, and %BSA affected meet the criteria specified in the study protocol
排除标准
- •Patients with a current significant skin or inflammatory condition that, in the opinion of the investigator or subinvestigator, would make it difficult to interpret data or assessments during the study
- •Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella) skin infection within 1 week prior to Week 0
- •Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
- •Patients with serious concomitant disease(s)
- •Patients with a history or current cancer
结局指标
主要结局
-
Proportion of subjects with >= 75% improvement in EASI score from Baseline at Week 8
次要结局
未报告次要终点
研究者
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