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

• ClinicalTrials.gov Identifier: NCT00820950
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Results First Posted: February 8, 2022
• Last Update Posted: February 8, 2022
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Ruxolitinib phosphate cream; Drug: Dovonex® calcipotriene 0.005%; Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Drug: Placebo cream	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 31, 2007
• Actual Primary Completion Date: January 31, 2009
• Actual Study Completion Date: April 30, 2009

Arms and Interventions

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 Name: INCB018424; Drug: Placebo cream; Cream applied once or twice daily for 56 days
Experimental: Cohort B: INCB018424 Ruxolitinib 1.0%; INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days	Drug: Placebo cream; Cream applied once or twice daily for 56 days; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.0%; Other Name: INCB018424
Experimental: Cohort C: INCB018424 Ruxolitinib 1.5%; INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days	Drug: Placebo cream; Cream applied once or twice daily for 56 days; Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.5%; Other Name: 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

Outcome Measures

Primary Outcome Measures :

1. Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline [ Time Frame: 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).
2. Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline [ Time Frame: 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).
3. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 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.
4. Pharmacokinetics Parameter : Skin Flux of INCB018424 [ Time Frame: Days 8, 15, 22, and 28 ]
   The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
5. Pharmacokinetics Parameter : Bioavailability of INCB018424 [ Time Frame: 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 :

1. Change in Target Lesion Area Compared to Baseline [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Vallejo, California, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, New York

Rochester, New York, United States

Stony Brook, New York, United States

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: William Williams, MD; Incyte Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT00820950
• Other Study ID Numbers: INCB 18424-201
• First Posted: January 12, 2009
• Results First Posted: February 8, 2022
• Last Update Posted: February 8, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents