Dermatitis

A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Incyte Study ID:
INCB 18424-206
CT.gov ID:
NCT03011892
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 purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: Ruxolitinib 0.15% Cream QD
  • Drug: Ruxolitinib 0.5% Cream QD
  • Drug: Ruxolitinib 1.5% Cream QD
  • Drug: Ruxolitinib 1.5% Cream BID
  • Drug: Triamcinolone 0.1% Cream BID
  • Drug: Vehicle Cream BID
    • COLLABORATORS
    N/A
    DATE
    Jan 2017 - Jan 2018
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18 - 70 Years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
    • Participants with a history of AD for at least 2 years.

    Exclusion Criteria

    • Participants with evidence of active acute or chronic infections.
    • Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.

    Clinical Study Locations

    Location
    Status
    Location
    UAB DERMATOLOGY, 2000 6th Avenue South
    Birmingham, Alabama, US, 35233
    Status
    Completed
    Location
    BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
    Bryant, Arkansas, US, 72022
    Status
    Completed
    Location
    ENCINO RESEARCH CENTER, 16133 Ventura Blvd
    Encino, CA, US, 91436
    Status
    Completed
    Location
    DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
    Los Angeles, CA, US, 90045
    Status
    Completed
    Location
    DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
    Oceanside, CA, US, 92056
    Status
    Completed
    Location
    INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
    Riverside, CA, US, 92506
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 18424-206
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    307
    Primary Outcome
    Open

    Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 4 in subjects treated with 1.5% ruxolitinib BID compared with subjects treated with vehicle cream BID

    Timeframe: From baseline to Week 4

    Secondary Outcome
    Open

    Mean percentage change from baseline in EASI score at Week 4 in subjects treated with ruxolitinib compared with subjects treated with vehicle cream BID

    Timeframe: From baseline to Week 4

    Mean percentage change from baseline in EASI score at Week 4 in subjects treated with ruxolitinib compared with subjects treated with triamcinolone 0.1% cream BID

    Timeframe: From baseline to Week 4

    Proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 to 1 who have an improvement of ≥ 2 points from baseline at Week 4

    Timeframe: From baseline to Week 4

    Mean change from baseline in the Itch Numerical Rating Scale (NRS) score at Week 4

    Timeframe: From baseline to Week 4

    Safety and tolerability assessed by monitoring the frequency, duration, and severity of adverse events (AEs)

    Timeframe: From baseline to 1 month after end of treatment, up to 16 weeks