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OpenTrials
Completed

NCT Number: NCT00617994

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fridley, Minnesota, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ruxolitinib

Drug

Ruxolitinib 1.5% cream BID for 28 days

Other names: INCB018424

Primary outcomes

  1. Number of Treatment of Emergent Adverse Events

    Time frame: Approximately 3 months

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

  2. Pharmacokinetics Parameter : Skin Flux of INCB018424

    Time frame: Days 1, 4, 8, 15, 22, and 28-30

    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.

  3. Pharmacokinetics Parameter: Bioavailability of INCB018424

    Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28

    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.

  4. Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424

    Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28

    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 outcomes

  1. Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline

    Time frame: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)

    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.

  2. Mean Change in Psoriatic Lesion Area

    Time frame: Days 1 and 28

    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.

  3. Mean Change in Physicians Global Assessment Score

    Time frame: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later

    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.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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).

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2008
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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