A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 199
- 主要终点
- Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
研究概览
简要总结
The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Plaque psoriasis involving up to 2 to 20% Body Surface Area
排除标准
- •Lesions solely involving intertriginous areas, the scalp or the face
- •Systemic therapy for their psoriasis
- •Pustular psoriasis or erythroderma
- •Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication
- •Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
- •Receiving systemic triazole antifungals except fluconazole
研究组 & 干预措施
Vehicle Cream
Vehicle cream, applied topically, once daily from Day 1 to Week 12.
干预措施: Placebo Cream (Other)
Ruxolitinib Phosphate 0.5% Cream
Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.
干预措施: Ruxolitinib Phosphate (Drug)
Ruxolitinib Phosphate 1.0% Cream
Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.
干预措施: Ruxolitinib Phosphate (Drug)
Ruxolitinib Phosphate 1.5% Cream
Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.
干预措施: Ruxolitinib Phosphate (Drug)
结局指标
主要结局
Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
时间窗: From Baseline (Day 1) to Day 84
Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.
次要结局
- Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema(From Baseline (Day 1) to Day 84)
- Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score(Baseline (Day 1) to Day 84)
- Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness(From Baseline (Day 1) to Day 84)
- Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling(From Baseline (Day 1) to Day 84)
- Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84(Day 84)
- Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA(Day 84)
- Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score(Baseline (Day 1) to Day 84)
- Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State(Pre-application on Days 1, 15, 28, 56, and 84)
- Percent Change From Baseline in the PASI Score(Baseline (Day 1) to Day 84)
- Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point(Baseline (Day 1) and Days 15, 28, 56, 84, and 112)
- Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness(From Baseline (Day 1) to Day 84)
- Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84(Day 84)
- Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84(Day 84)
- Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)(Baseline (Day 1) to Day 84)
- Percent Change From Baseline in the PGA Score(Baseline (Day 1) to Day 84)
- Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema(From Baseline (Day 1) to Day 84)
- Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling(From Baseline (Day 1) to Day 84)