Back to resultsOpen Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subjects must have psoriatic lesions measuring protocol specific BSA
Exclusion Criteria:
- Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
- Pustular psoriasis or erythroderma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Arm Description
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
Outcomes
Primary Outcome Measures
Number of Treatment of Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was 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.
Pharmacokinetics Parameter: Bioavailability of INCB018424
The INCB018424 bioavailability was 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.
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Secondary Outcome Measures
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Mean Change in Psoriatic Lesion Area
The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Mean Change in Physicians Global Assessment Score
The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.
Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00617994
Brief Title
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
Official Title
An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2007 (Actual)
Primary Completion Date
April 30, 2009 (Actual)
Study Completion Date
May 31, 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
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
INCB018424
Intervention Description
Ruxolitinib 1.5% cream BID for 28 days
Primary Outcome Measure Information:
Title
Number of Treatment of Emergent Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time Frame
Approximately 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 subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time Frame
Days 1, 4, 8, 15, 22, and 28-30
Title
Pharmacokinetics Parameter: Bioavailability of INCB018424
Description
The INCB018424 bioavailability was 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.
Time Frame
Approximately one month: Days 1, 4, 8, 15, 22, and 28
Title
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
Description
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Time Frame
Approximately one month: Days 1, 4, 8, 15, 22, and 28
Secondary Outcome Measure Information:
Title
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Description
Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Time Frame
Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
Title
Mean Change in Psoriatic Lesion Area
Description
The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Time Frame
Days 1 and 28
Title
Mean Change in Physicians Global Assessment Score
Description
The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.
Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Time Frame
Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have psoriatic lesions measuring protocol specific BSA
Exclusion Criteria:
Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
Pustular psoriasis or erythroderma
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
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77840
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis
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