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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A: INCB018424 Ruxolitinib 0.5%

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

Group Type EXPERIMENTAL

Ruxolitinib phosphate cream

Intervention Type DRUG

Ruxolitinib phosphate cream 0.5%

Placebo cream

Intervention Type DRUG

Cream applied once or twice daily for 56 days

Cohort B: INCB018424 Ruxolitinib 1.0%

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

Group Type EXPERIMENTAL

Placebo cream

Intervention Type DRUG

Cream applied once or twice daily for 56 days

Ruxolitinib phosphate cream

Intervention Type DRUG

Ruxolitinib phosphate cream 1.0%

Cohort C: INCB018424 Ruxolitinib 1.5%

INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

Group Type EXPERIMENTAL

Placebo cream

Intervention Type DRUG

Cream applied once or twice daily for 56 days

Ruxolitinib phosphate cream

Intervention Type DRUG

Ruxolitinib phosphate cream 1.5%

Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

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

Group Type EXPERIMENTAL

Dovonex® calcipotriene 0.005%

Intervention Type DRUG

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

Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

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

Group Type EXPERIMENTAL

Diprolene® AF betamethasone dipropionate 0.05% cream.

Intervention Type DRUG

Cream applied once or twice daily for up to 56 days

Interventions

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Ruxolitinib phosphate cream

Ruxolitinib phosphate cream 0.5%

Intervention Type DRUG

Dovonex® calcipotriene 0.005%

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

Intervention Type DRUG

Diprolene® AF betamethasone dipropionate 0.05% cream.

Cream applied once or twice daily for up to 56 days

Intervention Type DRUG

Placebo cream

Cream applied once or twice daily for 56 days

Intervention Type DRUG

Ruxolitinib phosphate cream

Ruxolitinib phosphate cream 1.0%

Intervention Type DRUG

Ruxolitinib phosphate cream

Ruxolitinib phosphate cream 1.5%

Intervention Type DRUG

Other Intervention Names

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INCB018424 INCB018424 INCB018424

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No