Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
- Registration Number
- NCT00617994
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Subjects must have psoriatic lesions measuring protocol specific BSA
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Ruxolitinib Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. Group B Ruxolitinib Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. Group C Ruxolitinib Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
- Primary Outcome Measures
Name Time Method Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 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 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 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 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.
- Secondary Outcome Measures
Name Time Method 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) Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Mean Change in Psoriatic Lesion Area Days 1 and 28 The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Mean Change in Physicians Global Assessment Score Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.
Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.