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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Ruxolitinib phosphate cream; Drug: Placebo cream; Drug: Ruxolitinib phosphate cream; Drug: Ruxolitinib phosphate cream; Drug: Dovonex® calcipotriene 0.005%; Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Vallejo, California, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • New York
    • Rochester, New York, United States
    • Stony Brook, New York, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: INCB018424 Ruxolitinib 0.5%; INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 0.5%; Other Names: INCB018424; Drug: Placebo cream; Cream applied once or twice daily for 56 days; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.0%; Other Names: INCB018424; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.5%; Other Names: INCB018424
Experimental: Cohort B: INCB018424 Ruxolitinib 1.0%; INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 0.5%; Other Names: INCB018424; Drug: Placebo cream; Cream applied once or twice daily for 56 days; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.0%; Other Names: INCB018424; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.5%; Other Names: INCB018424
Experimental: Cohort C: INCB018424 Ruxolitinib 1.5%; INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 0.5%; Other Names: INCB018424; Drug: Placebo cream; Cream applied once or twice daily for 56 days; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.0%; Other Names: INCB018424; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.5%; Other Names: INCB018424
Experimental: Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene; INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days	Drug: Dovonex® calcipotriene 0.005%; Cream applied once or twice daily for up to 56 days.
Experimental: 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	Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Cream applied once or twice daily for up to 56 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: William Williams, MD, Incyte Corporation

Publications and helpful links

General Publications

• Punwani N, Scherle P, Flores R, Shi J, Liang J, Yeleswaram S, Levy R, Williams W, Gottlieb A. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012 Oct;67(4):658-64. doi: 10.1016/j.jaad.2011.12.018. Epub 2012 Jan 24.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2007
• Primary Completion (Actual): January 31, 2009
• Study Completion (Actual): April 30, 2009

Study Registration Dates

• First Submitted: January 8, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 12, 2009

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: INCB 18424-201