The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

Last updated: March 27, 2025
Sponsor: Incyte Corporation
Overall Status: Terminated

Phase

4

Condition

Rash

Allergy

Eczema (Atopic Dermatitis)

Treatment

ruxolitinib cream

Clinical Study ID

NCT05696392
INCB 18424-902
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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).

  • Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening andbaseline visits.

  • Has an IGA score ≥ 2 at the screening and baseline visits.

  • Has an Itch NRS score ≥ 4 at the screening and baseline visits.

  • Willing to complete the once-daily Itch NRS (24-hour recall period) entries atapproximately the same time each day during the study.

  • Agrees to maintain a regular sleep schedule during the study period.

  • Willing and able to follow required study procedures for measuring sleep for theduration of the study.

Exclusion

Exclusion Criteria:

  • Currently using a wearable or other device for monitoring sleep patterns andunwilling to discontinue its use during the study.

  • Currently has a schedule that includes nighttime work shifts.

  • Has had significant flares or unstable course in AD (ie, condition worsenedsignificantly or required significant change in medications, as per medicaljudgment) in the previous 4 weeks before screening (information obtained frommedical chart, participant's physician, or directly from the participant).

  • Has received any ultraviolet B phototherapy (including tanning beds) or excimerlaser within 4 weeks prior to the screening period.

  • Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screeningperiod.

  • Has received a nonbiological investigational product or device within 4 weeks priorto the screening period, or is currently enrolled in another investigational drugstudy.

  • Has received treatment with JAK inhibitors (systemic or topical) within 4 weeksprior to the screening period.

  • Has had prior treatment with a JAK inhibitor that was discontinued for safetyreasons or tolerance problems.

  • Has a known or suspected allergy to ruxolitinib or any component of the study drug.

Study Design

Total Participants: 47
Treatment Group(s): 1
Primary Treatment: ruxolitinib cream
Phase: 4
Study Start date:
March 16, 2023
Estimated Completion Date:
January 22, 2025

Connect with a study center

  • First Oc Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Site Not Available

  • Gw Training Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • The Gw Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Skin Care Research, Llc

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Trueblue Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Driven Research Llc

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • University of Florida Health Dermatology-Springhill

    Gainesville, Florida 32606
    United States

    Site Not Available

  • Skin Care Research, Llc Scr Hollywood

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Ciocca Dermatology Pa

    Miami, Florida 33173
    United States

    Site Not Available

  • Skin Research of South Florida, Llc

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Trueblue Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Dermatology Specialists Research Indiana

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group Llc

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Skin Sciences Pllc

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Northeast Dermatology Associates

    Beverly, Massachusetts 01915
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center (Bidmc)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Northeast Dermatology Associates

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Essential Dermatology

    Natick, Massachusetts 01760
    United States

    Site Not Available

  • Washington University School of Medicine Dermatology

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Suny Downstate Health Sciences University

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Empire Dermatology

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Sadick Dermatology

    New York, New York 10075
    United States

    Site Not Available

  • Skin Search of Rochester

    Rochester, New York 14623
    United States

    Site Not Available

  • Ohio Pediatric Research Association

    Dayton, Ohio 45414
    United States

    Site Not Available

  • Knight Cancer Institute At Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Site Not Available

  • Arlington Research Center, Inc

    Arlington, Texas 76011
    United States

    Active - Recruiting

  • Jordan Valley Dermatology Center

    South Jordan, Utah 84095
    United States

    Site Not Available

  • Pi Coor Clinical Research Llc

    Burke, Virginia 22015
    United States

    Site Not Available

  • Clinical Research Partners Llc

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Dermatology Specialists of Spokane

    Spokane, Washington 99202
    United States

    Site Not Available

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