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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib phosphate cream
Dovonex® calcipotriene 0.005%
Diprolene® AF betamethasone dipropionate 0.05% cream.
Placebo cream
Ruxolitinib phosphate cream
Ruxolitinib phosphate cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A: INCB018424 Ruxolitinib 0.5%

Cohort B: INCB018424 Ruxolitinib 1.0%

Cohort C: INCB018424 Ruxolitinib 1.5%

Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene

Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate

Arm Description

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

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

INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days

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

INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

Outcomes

Primary Outcome Measures

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).
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).
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.
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 8, 2009
Last Updated
February 7, 2022
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00820950
Brief Title
A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2007 (Actual)
Primary Completion Date
January 31, 2009 (Actual)
Study Completion Date
April 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: INCB018424 Ruxolitinib 0.5%
Arm Type
Experimental
Arm Description
INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
Arm Title
Cohort B: INCB018424 Ruxolitinib 1.0%
Arm Type
Experimental
Arm Description
INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
Arm Title
Cohort C: INCB018424 Ruxolitinib 1.5%
Arm Type
Experimental
Arm Description
INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
Arm Title
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene
Arm Type
Experimental
Arm Description
INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days
Arm Title
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate
Arm Type
Experimental
Arm Description
INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib phosphate cream
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib phosphate cream 0.5%
Intervention Type
Drug
Intervention Name(s)
Dovonex® calcipotriene 0.005%
Intervention Description
Cream applied once or twice daily for up to 56 days.
Intervention Type
Drug
Intervention Name(s)
Diprolene® AF betamethasone dipropionate 0.05% cream.
Intervention Description
Cream applied once or twice daily for up to 56 days
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Intervention Description
Cream applied once or twice daily for 56 days
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib phosphate cream
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib phosphate cream 1.0%
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib phosphate cream
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib phosphate cream 1.5%
Primary Outcome Measure Information:
Title
Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
Description
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).
Time Frame
Baseline, Days 8, 15, 22, 28 and 56
Title
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
Description
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).
Time Frame
Baseline, Days 8, 15, 22, 28 and 56
Title
Number of Participants With Treatment Emergent Adverse Events
Description
A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
3 months
Title
Pharmacokinetics Parameter : Skin Flux of INCB018424
Description
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Time Frame
Days 8, 15, 22, and 28
Title
Pharmacokinetics Parameter : Bioavailability of INCB018424
Description
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.
Time Frame
Days 8, 15, 22, and 28
Secondary Outcome Measure Information:
Title
Change in Target Lesion Area Compared to Baseline
Description
Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Williams, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Vallejo
State/Province
California
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22281165
Citation
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.
Results Reference
derived

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

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