NCT03961529已完成3 期
A Multicenter, Open-label, Uncontrolled, Long-term Trialto Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients With Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients With Atopic Dermatitis (Phase 3 Trial)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: At least 2 years (at time of obtaining informed consent)
- •Diagnosis of AD based on the Japanese Dermatological Association's criteria
- •Atopic dermatitis affecting ≥5% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
排除标准
- •Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination
研究组 & 干预措施
0.3% OPA-15406 ointment
Experimental
Twice daily
干预措施: 0.3% OPA-15406 ointment (Drug)
1% OPA-15406 ointment
Experimental
Twice daily
干预措施: 1% OPA-15406 ointment (Drug)
结局指标
主要结局
Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
时间窗: Treatment period (52 weeks)
The number of subjects were calculated regarding adverse events occurring after IMP administration (=TEAEs).
次要结局
- Responder Rate of Investigator's Global Assessment (IGA)(Week 52)
- Responder Rate of Eczema Area and Severity Index 75 (EASI 75)(Week 52)
研究者
研究点 (1)
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