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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820950
• Other study ID #: INCB 18424-201
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2007
• Est. completion date: April 30, 2009

Study information

• Verified date: February 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 30, 2009
• Est. primary completion date: January 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Ruxolitinib phosphate cream
Ruxolitinib phosphate cream 0.5%
• Dovonex® calcipotriene 0.005%
Cream applied once or twice daily for up to 56 days.
• Diprolene® AF betamethasone dipropionate 0.05% cream.
Cream applied once or twice daily for up to 56 days
• Placebo cream
Cream applied once or twice daily for 56 days
• Ruxolitinib phosphate cream
Ruxolitinib phosphate cream 1.0%
• Ruxolitinib phosphate cream
Ruxolitinib phosphate cream 1.5%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline	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).	Baseline, Days 8, 15, 22, 28 and 56
Primary	Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline	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).	Baseline, Days 8, 15, 22, 28 and 56
Primary	Number of Participants With Treatment Emergent Adverse Events	A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.	3 months
Primary	Pharmacokinetics Parameter : Skin Flux of INCB018424	The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.	Days 8, 15, 22, and 28
Primary	Pharmacokinetics Parameter : Bioavailability of INCB018424	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.	Days 8, 15, 22, and 28
Secondary	Change in Target Lesion Area Compared to Baseline	Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.	Day 28