Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

Study Overview
=================
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.

Official Title
-----------------
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).

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Ruxolitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have psoriatic lesions measuring protocol specific BSA Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. | Drug: Ruxolitinib<br>* Ruxolitinib 1.5% cream BID for 28 days<br>* Other names: INCB018424;|
| Experimental: Group B<br>Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. | Drug: Ruxolitinib<br>* Ruxolitinib 1.5% cream BID for 28 days<br>* Other names: INCB018424;|
| Experimental: Group C<br>Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2. | Drug: Ruxolitinib<br>* Ruxolitinib 1.5% cream BID for 28 days<br>* Other names: INCB018424;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment of Emergent Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment | Approximately 3 months | 
| Pharmacokinetics Parameter : Skin Flux of INCB018424 | 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. | Days 1, 4, 8, 15, 22, and 28-30 | 
| Pharmacokinetics Parameter: Bioavailability of INCB018424 | 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. | Approximately one month: Days 1, 4, 8, 15, 22, and 28 | 
| Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424 | 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. | Approximately one month: Days 1, 4, 8, 15, 22, and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline | 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. | Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up) | 
| Mean Change in Psoriatic Lesion Area | 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. | Days 1 and 28 | 
| Mean Change in Physicians Global Assessment Score | 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. | Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis