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

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).

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Ruxolitinib

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Fridley, Minnesota, United States, 55432
  • New York
    • Rochester, New York, United States, 14623
  • Texas
    • Austin, Texas, United States, 78759
    • College Station, Texas, United States, 77840

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424
Experimental: Group B; Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424
Experimental: Group C; Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.	Drug: Ruxolitinib; Ruxolitinib 1.5% cream BID for 28 days; Other Names: INCB018424

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: William Williams, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2007
• Primary Completion (Actual): April 30, 2009
• Study Completion (Actual): May 31, 2009

Study Registration Dates

• First Submitted: January 21, 2008
• First Submitted That Met QC Criteria: February 6, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: INCB 18424-202