Psoriasis

A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Incyte Study ID:
INCB 18424-203
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Study Complete
Subscribe to Updates

Clinical Study Purpose

The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Psoriasis
  • PRODUCT
  • Drug: Ruxolitinib Phosphate
  • COLLABORATORS
    N/A
    DATE
    Oct 2008 - Jun 2009
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 75 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Plaque psoriasis involving up to 2 to 20% Body Surface Area

    Exclusion Criteria

    • Lesions solely involving intertriginous areas, the scalp or the face
    • Systemic therapy for their psoriasis

    Clinical Study Locations

    Location
    Status
    Location
    Miami, FL, US
    Status
    Active, not recruiting
    Location
    Naperville, IL, US
    Status
    Active, not recruiting
    Location
    Houston, TX, US
    Status
    Active, not recruiting
    Location
    Salt Lake City, UT, US
    Status
    Active, not recruiting
    Location
    Norman, OK, US
    Status
    Active, not recruiting
    Location
    Boston, MA, US
    Status
    Active, not recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-203
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
    Other
    Enrollment:
    199
    Primary Outcome
    Open

    Absolute change from Baseline to Day 84 in total lesion score for all treatable psoriatic lesions.

    Timeframe: Baseline and Day 84 (or early study termination visit)

    Secondary Outcome
    Open

    Percentage of subjects achieving none (score=0) and mild (score=1) in each of the individual lesion scores at Day 84

    Timeframe: Baseline and Day 84