A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 75
- 主要终点
- Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
研究概览
简要总结
This was a Phase 3, 4-week, double-blind study to assess the safety and efficacy of ARQ-151 cream compared to vehicle cream applied once daily (qd) for 4 weeks in children 2 to 5 years of age with atopic dermatitis (AD).
详细描述
This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent by parent(s) or legal guardian as required by local laws.
- •Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
- •Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
- •In good health as judged by the Investigator.
- •Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
排除标准
- •Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
- •Has unstable AD or any consistent requirement for high potency topical steroids.
- •Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
- •Previous treatment with ARQ-
- •Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- •Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.
研究组 & 干预措施
Roflumilast Cream 0.05%
Participants applied roflumilast cream 0.05% qd for 4 weeks.
干预措施: Roflumilast Cream 0.05% (Drug)
Vehicle Cream
Participants applied vehicle cream qd for 4 weeks.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4
时间窗: Week 4
The percentage of participants with vIGA-AD success at Week 4 is presented. The vIGA-AD is a static evaluation of qualitative overall AD severity with five severity grades (reported as score of 0 'clear' to 4 'severe' with higher scores indicating greater symptom severity. vIGA success was defined as score of 'clear' or 'almost clear' plus a 2-grade improvement from baseline.
次要结局
- Achievement of vIGA-AD Success at Week 4 in Participants With 'Moderate' Baseline vIGA-AD(Week 4)
- Achievement of 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 In Participants With 'Moderate' Baseline vIGA(Week 4)
- Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear'(Week 4)
- Achievement of vIGA-AD Success at Week 2(Week 2)
- Achievement of vIGA-AD Success at Week 1(Week 1)
- Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 2(Week 2)
- Achievement of vIGA-AD of 'Clear' or 'Almost Clear' at Week 1(Week 1)