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

NCT00820950 | Completed Phase 2 Results

• 1 other identifier: INCB 18424-201
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Change in Target Lesion Area Compared to Baseline

  Day 28

Study Arms (5)

Cohort A: INCB018424 Ruxolitinib 0.5%

EXPERIMENTAL

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

Drug: Ruxolitinib phosphate cream; Drug: Placebo cream

Cohort B: INCB018424 Ruxolitinib 1.0%

EXPERIMENTAL

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

Drug: Placebo cream; Drug: Ruxolitinib phosphate cream

Cohort C: INCB018424 Ruxolitinib 1.5%

EXPERIMENTAL

INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

Drug: Placebo cream; Drug: Ruxolitinib phosphate cream

Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

EXPERIMENTAL

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

Drug: Dovonex® calcipotriene 0.005%

Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

EXPERIMENTAL

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.

Interventions

Ruxolitinib phosphate cream DRUG

Ruxolitinib phosphate cream 0.5%

Also known as: INCB018424

Cohort A: INCB018424 Ruxolitinib 0.5%

Dovonex® calcipotriene 0.005% DRUG

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

Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

Diprolene® AF betamethasone dipropionate 0.05% cream. DRUG

Cream applied once or twice daily for up to 56 days

Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

Placebo cream DRUG

Cream applied once or twice daily for 56 days

Cohort A: INCB018424 Ruxolitinib 0.5%; Cohort B: INCB018424 Ruxolitinib 1.0%; Cohort C: INCB018424 Ruxolitinib 1.5%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (6)

Unknown Facility

Vallejo, California, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Stony Brook, New York, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• 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.

  PMID: 22281165 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Incyte Corporation Call Center (US)
• Organization: Incyte

medinfo@incyte.com

1.855.463.3463

Study Officials

• William Williams, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: May 31, 2007
• Primary Completion: January 31, 2009
• Study Completion: April 30, 2009
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-02

Locations

US (6)