Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

Psoriasis Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617994
• Other study ID #: INCB 18424-202
• Status: Completed
• Phase: Phase 2
• Start date: August 31, 2007
• Est. completion date: May 31, 2009

Study information

• Verified date: February 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2009
• Est. primary completion date: April 30, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Ruxolitinib
Ruxolitinib 1.5% cream BID for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 3 months
Primary	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.	Days 1, 4, 8, 15, 22, and 28-30
Primary	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.	Approximately one month: Days 1, 4, 8, 15, 22, and 28
Primary	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.	Approximately one month: Days 1, 4, 8, 15, 22, and 28
Secondary	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.	Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
Secondary	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.	Days 1 and 28
Secondary	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.	Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later