A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib 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
- 29
- 主要终点
- Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
研究概览
简要总结
The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.
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
- •Body Mass Index (BMI) of 17 to 40 kg/m2
- •Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2 and these target lesions must be similar in size to each other, and separated by at least 15 cm.
排除标准
- •Subjects with lesions solely involving the palms of the hands or soles of the feet or intertriginous areas, the scalp or the face.
- •Subjects with pustular psoriasis or erythroderma.
- •Subjects currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication.
- •Subjects receiving PUVA within 4 weeks of the first dose of study medication.
- •Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral immunosuppressives within 3 months prior to the first dose of study medication.
- •Subjects receiving any other biological therapy (infliximab, alefacept, abatacept, etc) within 3 months of the first dose of study medication.
研究组 & 干预措施
Cohort A: INCB018424 Ruxolitinib 0.5%
INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
干预措施: Ruxolitinib phosphate cream (Drug)
Cohort A: INCB018424 Ruxolitinib 0.5%
INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
干预措施: Placebo cream (Drug)
Cohort B: INCB018424 Ruxolitinib 1.0%
INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
干预措施: Placebo cream (Drug)
Cohort B: INCB018424 Ruxolitinib 1.0%
INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
干预措施: Ruxolitinib phosphate cream (Drug)
Cohort C: INCB018424 Ruxolitinib 1.5%
INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
干预措施: Placebo cream (Drug)
Cohort C: INCB018424 Ruxolitinib 1.5%
INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
干预措施: Ruxolitinib phosphate cream (Drug)
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene
INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days
干预措施: Dovonex® calcipotriene 0.005% (Drug)
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate
INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days
干预措施: Diprolene® AF betamethasone dipropionate 0.05% cream. (Drug)
结局指标
主要结局
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
时间窗: Baseline, Days 8, 15, 22, 28 and 56
The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
时间窗: Baseline, Days 8, 15, 22, 28 and 56
The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Number of Participants With Treatment Emergent Adverse Events
时间窗: 3 months
A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Pharmacokinetics Parameter : Skin Flux of INCB018424
时间窗: Days 8, 15, 22, and 28
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Pharmacokinetics Parameter : Bioavailability of INCB018424
时间窗: Days 8, 15, 22, and 28
The INCB018424 bioavailability will be 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. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.
次要结局
- Change in Target Lesion Area Compared to Baseline(Day 28)