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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Dovonex® calcipotriene 0.005%; Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Drug: Ruxolitinib phosphate cream; Drug: Placebo cream

• Registration Number: NCT00820950
• Lead Sponsor: Incyte Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-31
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2009-01-31
• Study Completion: 2009-04-30
• Disposition First Submitted: 2010-06-17
• Disposition First Submitted QC: 2010-06-17
• Disposition First Posted: 2010-06-22
• Results First Submitted: 2021-10-18
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Results First Posted: 2022-02-08
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A: INCB018424 Ruxolitinib 0.5%	Placebo cream	INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
Cohort B: INCB018424 Ruxolitinib 1.0%	Placebo cream	INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
Cohort C: INCB018424 Ruxolitinib 1.5%	Placebo cream	INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene	Dovonex® calcipotriene 0.005%	INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate	Diprolene® AF betamethasone dipropionate 0.05% cream.	INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days
Cohort A: INCB018424 Ruxolitinib 0.5%	Ruxolitinib phosphate cream	INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
Cohort B: INCB018424 Ruxolitinib 1.0%	Ruxolitinib phosphate cream	INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
Cohort C: INCB018424 Ruxolitinib 1.5%	Ruxolitinib phosphate cream	INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

Primary Outcome Measures

Name	Time	Method
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline	Baseline, Days 8, 15, 22, 28 and 56	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).
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline	Baseline, Days 8, 15, 22, 28 and 56	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).
Number of Participants With Treatment Emergent Adverse Events	3 months	A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Pharmacokinetics Parameter : Skin Flux of INCB018424	Days 8, 15, 22, and 28	The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Pharmacokinetics Parameter : Bioavailability of INCB018424	Days 8, 15, 22, and 28	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.

Secondary Outcome Measures

Name	Time	Method
Change in Target Lesion Area Compared to Baseline	Day 28	Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.