A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 40
- 主要终点
- Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
研究概览
简要总结
This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.
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 —（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 2 years and older (inclusive)
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
- •Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
- •In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
- •Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
排除标准
- •Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Previous treatment with ARQ-151 or its active ingredient
- •Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- •Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product
- •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
研究组 & 干预措施
Rofumilast Cream 0.3%
Participants receive roflumilast cream 0.3% once daily for 8 weeks.
干预措施: Roflumilast 0.3% cream (Drug)
Vehicle cream
Participants receive vehicle cream once daily for 8 weeks.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
时间窗: Baseline (Day 1) and Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented (observed data only) for each arm. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
次要结局
- Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)(From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days))
- Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)(Baseline (Day 1) and Week 8)
- Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)(Baseline (Day 1) and Week 8)
- Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8(Baseline (Day 1) and Week 8)
- Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8(Week 8)
- Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success(Baseline (Day 1) and Weeks 2, 4, and 8)
- Change From Baseline in Psoriasis Symptoms Diary (PSD) Score(Weeks 4 and 8)