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Completed

NCT Number: NCT00820950

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vallejo, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ruxolitinib phosphate cream

Drug

Ruxolitinib phosphate cream 0.5%

Other names: INCB018424

Dovonex® calcipotriene 0.005%

Drug

Cream applied once or twice daily for up to 56 days.

Diprolene® AF betamethasone dipropionate 0.05% cream.

Drug

Cream applied once or twice daily for up to 56 days

placebo cream

Drug

Cream applied once or twice daily for 56 days

Primary outcomes

  1. Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

    Time frame: Baseline, Days 8, 15, 22, 28 and 56

    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).

  2. Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

    Time frame: Baseline, Days 8, 15, 22, 28 and 56

    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).

  3. Number of Participants With Treatment Emergent Adverse Events

    Time frame: 3 months

    A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.

  4. Pharmacokinetics Parameter : Skin Flux of INCB018424

    Time frame: Days 8, 15, 22, and 28

    The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.

  5. Pharmacokinetics Parameter : Bioavailability of INCB018424

    Time frame: Days 8, 15, 22, and 28

    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 outcomes

  1. Change in Target Lesion Area Compared to Baseline

    Time frame: Day 28

    Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2009
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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