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

Incyte

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Dovonex® calcipotriene 0.005%; Drug: Ruxolitinib phosphate cream; Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Drug: Placebo cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820950

INCB 18424-201

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

29 participants in 5 patient groups

Cohort A: INCB018424 Ruxolitinib 0.5%

Experimental group

Description:

INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days

Treatment:

Drug: Placebo cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Cohort B: INCB018424 Ruxolitinib 1.0%

Experimental group

Description:

INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days

Treatment:

Drug: Placebo cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Cohort C: INCB018424 Ruxolitinib 1.5%

Experimental group

Description:

INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

Treatment:

Drug: Placebo cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Drug: Ruxolitinib phosphate cream

Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

Experimental group

Description:

INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days

Treatment:

Drug: Dovonex® calcipotriene 0.005%

Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

Experimental group

Description:

INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

Treatment:

Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.