A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 654
- 试验地点
- 49
- 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 is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- •Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
- •Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
- •Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day
- •In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
- •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 and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Previous treatment with ARQ-
- •Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- •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 subjects living in the same house.
研究组 & 干预措施
Roflumilast Cream 0.15%
Participants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.
干预措施: Roflumilast Cream 0.15% (Drug)
Vehicle Cream
Participants with mild to moderate AD 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 achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear), with higher scores indicative of greater symptom severity.
次要结局
- Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores(Week 4)
- Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4(Week 4)
- Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4(Week 2)
- Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4(Week 1)
- Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4(Week 4)
- Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4(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 Score of 'Clear' or 'Almost Clear' at Week 2(Week 2)
- Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1(Week 1)