The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
NCT ID: NCT05696392
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
47 participants
INTERVENTIONAL
2023-03-16
2025-01-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group: Ruxolitinib
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
ruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Interventions
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ruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 and baseline 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 at approximately 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 the duration of the study.
Exclusion Criteria
* Currently has a schedule that includes nighttime work shifts.
* Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant).
* Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period.
* Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period.
* Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study.
* Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period.
* Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems.
* Has a known or suspected allergy to ruxolitinib or any component of the study drug.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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First Oc Dermatology
Fountain Valley, California, United States
Ark Clinical Research
Long Beach, California, United States
Gw Training Center
Washington D.C., District of Columbia, United States
Skin Care Research, Llc
Boca Raton, Florida, United States
Driven Research Llc
Coral Gables, Florida, United States
University of Florida Health Dermatology-Springhill
Gainesville, Florida, United States
Skin Care Research, Llc Scr Hollywood
Hollywood, Florida, United States
Ciocca Dermatology Pa
Miami, Florida, United States
Trueblue Clinical Research
Tampa, Florida, United States
Dermatology Specialists Research Indiana
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, United States
Skin Sciences Pllc
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States
Northeast Dermatology Associates
Methuen, Massachusetts, United States
Essential Dermatology
Natick, Massachusetts, United States
Washington University School of Medicine Dermatology
St Louis, Missouri, United States
Suny Downstate Health Sciences University
Brooklyn, New York, United States
Empire Dermatology
East Syracuse, New York, United States
Sadick Dermatology
New York, New York, United States
Skin Search of Rochester
Rochester, New York, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Arlington Research Center
Arlington, Texas, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Pi Coor Clinical Research Llc
Burke, Virginia, United States
Clinical Research Partners Llc
Richmond, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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The purpose of this study is to evaluate the effects of ruxolitinib cream on adults with atopic dermatitis experiencing sleep disturbance. (MORPHEUS)
Other Identifiers
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INCB 18424-902
Identifier Type: -
Identifier Source: org_study_id