A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 10
- 主要终点
- Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
研究概览
简要总结
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
详细描述
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis.
Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle.
Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Approx. 210 subjects randomized and 16 subjects will be in an open-label sub-study
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ATx201 OINTMENT 4%
ATx201 OINTMENT 4%
干预措施: ATx201 (Drug)
ATx201 OINTMENT 7%
ATx201 OINTMENT 7%
干预措施: ATx201 (Drug)
ATx201 OINTMENT vehicle
ATx201 OINTMENT vehicle
干预措施: ATx201 OINTMENT vehicle (Drug)
结局指标
主要结局
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
时间窗: Baseline to Week 6
EASI mean change from baseline at Week 6
次要结局
- Investigator Global Assessment (IGA) success(Baseline to Week 6)
- Mean change from baseline in Target lesion Total Sign Score (TSS)(Baseline to Week 6)
- change from baseline in Investigator Global Assessment (IGA) scoring(Baseline to Week 6)