A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

Phase 2CompletedNCT00820950

Incyte Corporation29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Psoriasis

Interventions

Ruxolitinib phosphate creamDRUG

Ruxolitinib phosphate cream 0.5%

Dovonex® calcipotriene 0.005%DRUG

Cream applied once or twice daily for up to 56 days.

Diprolene® AF betamethasone dipropionate 0.05% cream.DRUG

Cream applied once or twice daily for up to 56 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (6)

Unnamed facility

Vallejo, California, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Rochester, New York, United States

Unnamed facility

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

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).

Time frame: Baseline, Days 8, 15, 22, 28 and 56

Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

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).

Time frame: Baseline, Days 8, 15, 22, 28 and 56

Number of Participants With Treatment Emergent Adverse Events

A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.

Time frame: 3 months

Pharmacokinetics Parameter : Skin Flux of INCB018424

The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.

Time frame: Days 8, 15, 22, and 28

Pharmacokinetics Parameter : Bioavailability of INCB018424

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.

Time frame: Days 8, 15, 22, and 28

Secondary Outcomes

Data from ClinicalTrials.gov

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