An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
研究概览
简要总结
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have psoriatic lesions measuring protocol specific BSA
排除标准
- •Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
- •Pustular psoriasis or erythroderma
研究组 & 干预措施
Group A
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
干预措施: Ruxolitinib (Drug)
Group B
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
干预措施: Ruxolitinib (Drug)
Group C
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
时间窗: Approximately one month: Days 1, 4, 8, 15, 22, and 28
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Number of Treatment of Emergent Adverse Events
时间窗: Approximately 3 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Pharmacokinetics Parameter : Skin Flux of INCB018424
时间窗: Days 1, 4, 8, 15, 22, and 28-30
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Pharmacokinetics Parameter: Bioavailability of INCB018424
时间窗: Approximately one month: Days 1, 4, 8, 15, 22, and 28
The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
次要结局
- Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline(Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up))
- Mean Change in Psoriatic Lesion Area(Days 1 and 28)
- Mean Change in Physicians Global Assessment Score(Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later)