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

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

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.

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.