Protocol MEDI-MM36-206: A Phase 2 Multi-center, Open-label Study to Assess Pharmacokinetic Parameters and Safety of Topical MM36 (1%) in Pediatric Subjects 2 to < 18 Years of Age With Atopic Dermatitis Under Maximal Use Conditions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of MM36
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.
详细描述
This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 2 to <18 years of age
- •Diagnosis of atopic dermatitis (AD)
- •AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)
排除标准
- •Active or acute viral skin infection
- •History of recurrent bacterial infection
- •Malignancy
- •Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
研究组 & 干预措施
MM36 1% ointment
MM36 topical ointment, 1%, applied twice daily for 28 days
干预措施: MM36 topical ointment, 1% (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of MM36
时间窗: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)
Time of Maximum Observed Plasma Concentration (Tmax) of MM36
时间窗: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15
Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36
时间窗: Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15
Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15
次要结局
- Application Site Adverse Events (AEs)(up to 4 weeks)
- Clinically Meaningful ECG Median Changes From Baseline to Day 29(Day 29)
- Clinically Meaningful Vital Sign Median Changes From Baseline(Day 29)
- Clinically Meaningful Laboratory Test Median Changes From Baseline(Day 29)
- Clinically Meaningful ECG Median Changes From Baseline to Day 15(Day 15)
- Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(up to 4 weeks)
- Treatment-Emergent Adverse Events (AEs) According to Severity(up to 4 weeks)
- Application Site Adverse Events (AEs) According to Severity(up to 4 weeks)