NCT03638258已完成2 期
A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 30
- 主要终点
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
研究概览
简要总结
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
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
Roflumilast drug product will be supplied as a 0.3% and 0.15% cream. The matching vehicle cream will contain only excipients of roflumilast cream.
入排标准
- 年龄范围
- 18 Years 至 —（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
- •Males and females ages 18 years and older (inclusive)
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
- •Females of childbearing potential (FOCBP) must have a negative urine 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 are 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 or tanning bed.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Previous treatment with roflumilast cream 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 study medication.
- •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
Roflumilast Cream 0.3%
Experimental
Roflumilast cream 0.3% topically applied QD for 12 weeks.
干预措施: Roflumilast Cream 0.3% (Drug)
Roflumilast Cream 0.15%
Experimental
Roflumilast cream 0.15% topically applied QD for 12 weeks.
干预措施: Roflumilast Cream 0.15% (Drug)
Vehicle Cream
Placebo Comparator
Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
时间窗: Week 6
The percentage of participants with an IGA score of 0 ('clear') or 1 ('almost clear') at Week 6 is reported. The IGA is 5-point scale assessing the severity of plaque psoriasis, with scores ranging from 0 ('clear') to 4 ('severe'), with higher scores indicating greater plaque severity.
次要结局
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'(Weeks 4, 8, and 12)
- Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percent Change From Baseline in Body Surface Area (BSA) Affected(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline(Weeks 4, 6, 8, and 12)
- Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline (Day 1) and Weeks 4, 6, 8, and 12)
- Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)(Weeks 4, 6, 8, and 12)
研究者
研究点 (30)
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