Psoriasis

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

Incyte Study ID:
INCB 18424-201
CT.gov ID:
NCT00820950
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Psoriasis
    • PRODUCT
  • Drug: Ruxolitinib phosphate cream
  • Drug: Dovonex® calcipotriene 0.005%
  • Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.
  • Drug: Placebo cream
    • COLLABORATORS
    N/A
    DATE
    May 2007 - Jan 2009
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 75 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    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.

    Clinical Study Locations

    Location
    Status
    Location
    Boston, MA, US
    Status
    Completed
    Location
    Rochester, NY, US
    Status
    Completed
    Location
    Vallejo, California, US
    Status
    Completed
    Location
    Stony Brook, NY, US
    Status
    Completed
    Location
    Philadelphia, PA, US
    Status
    Completed
    Location
    Portland, Oregon, US
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 18424-201
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Drug
    Enrollment:
    29
    Primary Outcome
    Open

    Change in target lesion scores for Erythema, Scaling and Thickness compared to baseline

    Timeframe: Days 8, 15, 22, 28 and 56

    Change in total target lesion score (sum of Erythema + Scaling + Thickness) compared to baseline

    Timeframe: Days 8, 15, 22 and 56

    Number of Treatment of Emergent Adverse Events

    Timeframe: 3 months

    Pharmacokinetics Parameter : Skin flux of INCB018424

    Timeframe: Days 8, 15, 22, and 28

    Pharmacokinetics Parameter : Bioavailability of INCB018424

    Timeframe: Days 8, 15, 22, and 28

    Secondary Outcome
    Open

    Change in target lesion area compared to baseline

    Timeframe: Day 28