Dermatitis

The purpose of this study is to evaluate the effects of ruxolitinib cream on adults with atopic dermatitis experiencing sleep disturbance.

Incyte Study ID:
INCB 18424-902
CT.gov ID:
NCT05696392
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
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Clinical Study Purpose

The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Dermatitis
    • PRODUCT
  • Drug: ruxolitinib cream
    • COLLABORATORS
    N/A
    DATE
    Mar 2023 - Jan 2025
    TYPE
    Interventional
    PHASE
    Phase 4
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria.
    • Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant).

    Exclusion Criteria

    • Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study.
    • Currently has a schedule that includes nighttime work shifts.

    Clinical Study Locations

    Location
    Status
    Location
    KNIGHT CANCER INSTITUTE AT OREGON HEALTH AND SCIENCE UNIVERSITY
    PORTLAND, OR, US, 97239
    Status
    Completed
    Location
    FIRST OC DERMATOLOGY
    FOUNTAIN VALLEY, CA, US, 92708
    Status
    Completed
    Location
    GW TRAINING CENTER
    WASHINGTON, DC, US, 20037
    Status
    Completed
    Location
    SUNY DOWNSTATE HEALTH SCIENCES UNIVERSITY
    BROOKLYN, NY, US, 11203
    Status
    Completed
    Location
    ARLINGTON RESEARCH CENTER
    ARLINGTON, TX, US, 76011
    Status
    Completed
    Location
    DAWES FRETZIN CLINICAL RESEARCH GROUP LLC
    INDIANAPOLIS, IN, US, 46250
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 18424-902
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    47
    Primary Outcome
    Open

    Change from baseline in Total Sleep Time (TST)

    Timeframe: Week 8

    Secondary Outcome
    Open

    Change from baseline in PROMIS Sleep Disturbance

    Timeframe: Week 8