Study Stopped
The study was terminated due to lack of enrollment.
The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
MORPHEUS
An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
1 other identifier
interventional
47
1 country
30
Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2023
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2025
CompletedResults Posted
Study results publicly available
December 19, 2025
CompletedDecember 19, 2025
December 1, 2025
1.9 years
January 13, 2023
December 3, 2025
December 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8
TST is the total amount of time spent during a planned sleep episode. Decreased TST is indicative of increased sleep disturbance. Baseline TST was the average hours of sleep within the last 7 nights prior to Visit 1. The Week 8 TST was the average hours of sleep within the last 7 nights prior to Visit 3/Week 8. Change from baseline was calculated as the post-baseline value minus the baseline value.
Baseline; Week 8
Secondary Outcomes (1)
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8
Baseline; Week 8
Study Arms (1)
Treatment Group: Ruxolitinib
EXPERIMENTALruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
Interventions
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Eligibility Criteria
You may qualify if:
- 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 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
First Oc Dermatology
Fountain Valley, California, 92708, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Gw Training Center
Washington D.C., District of Columbia, 20037, United States
Skin Care Research, Llc
Boca Raton, Florida, 33486, United States
Driven Research Llc
Coral Gables, Florida, 33134, United States
University of Florida Health Dermatology-Springhill
Gainesville, Florida, 32606, United States
Skin Care Research, Llc Scr Hollywood
Hollywood, Florida, 33021, United States
Ciocca Dermatology Pa
Miami, Florida, 33173, United States
Trueblue Clinical Research
Tampa, Florida, 33609, United States
Dermatology Specialists Research Indiana
Clarksville, Indiana, 47129, United States
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, 46250, United States
Skin Sciences Pllc
Louisville, Kentucky, 40217, United States
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, 02215, United States
Northeast Dermatology Associates
Methuen, Massachusetts, 01844, United States
Essential Dermatology
Natick, Massachusetts, 01760, United States
Washington University School of Medicine Dermatology
St Louis, Missouri, 63110, United States
Suny Downstate Health Sciences University
Brooklyn, New York, 11203, United States
Empire Dermatology
East Syracuse, New York, 13057, United States
Sadick Dermatology
New York, New York, 10075, United States
Skin Search of Rochester
Rochester, New York, 14623, United States
Ohio Pediatric Research Association
Dayton, Ohio, 45414, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Arlington Research Center
Arlington, Texas, 76011, United States
Jordan Valley Dermatology Center
South Jordan, Utah, 84095, United States
Pi Coor Clinical Research Llc
Burke, Virginia, 22015, United States
Clinical Research Partners Llc
Richmond, Virginia, 23226, United States
Dermatology Specialists of Spokane
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early due to challenges with enrollment. Sample size was limited due to a high number of screen failures and important Protocol deviations.
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2023
First Posted
January 25, 2023
Study Start
March 16, 2023
Primary Completion
January 22, 2025
Study Completion
January 22, 2025
Last Updated
December 19, 2025
Results First Posted
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency.