Clinical trial NCT00820950: A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
timeFrame: Baseline, Days 8, 15, 22, 28 and 56
measure: Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
timeFrame: Baseline, Days 8, 15, 22, 28 and 56
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 3 months
measure: Pharmacokinetics Parameter : Skin Flux of INCB018424
timeFrame: Days 8, 15, 22, and 28
measure: Pharmacokinetics Parameter : Bioavailability of INCB018424
timeFrame: Days 8, 15, 22, and 28
Secondary outcomes:
measure: Change in Target Lesion Area Compared to Baseline
timeFrame: Day 28
Other outcomes:
Locations:
city: Vallejo
country: United States
state: California
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Incyte Corporation
name: William Williams, MD
role: STUDY_DIRECTOR
References:
citation: Punwani N, Scherle P, Flores R, Shi J, Liang J, Yeleswaram S, Levy R, Williams W, Gottlieb A. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012 Oct;67(4):658-64. doi: 10.1016/j.jaad.2011.12.018. Epub 2012 Jan 24.