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

December 3, 2025 updated by: Incyte Corporation

An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Long Beach, California, United States, 90815
        • ARK Clinical Research
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Gw Training Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, LLC
      • Coral Gables, Florida, United States, 33134
        • Driven Research LLC
      • Gainesville, Florida, United States, 32606
        • University of Florida Health Dermatology-Springhill
      • Hollywood, Florida, United States, 33021
        • Skin Care Research, Llc Scr Hollywood
      • Miami, Florida, United States, 33173
        • Ciocca Dermatology Pa
      • Tampa, Florida, United States, 33609
        • Trueblue Clinical Research
    • Indiana
      • Clarksville, Indiana, United States, 47129
        • Dermatology Specialists Research Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Research Group LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences PLLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
      • Methuen, Massachusetts, United States, 01844
        • Northeast Dermatology Associates
      • Natick, Massachusetts, United States, 01760
        • Essential Dermatology
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine Dermatology
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Health Sciences University
      • East Syracuse, New York, United States, 13057
        • Empire Dermatology
      • New York, New York, United States, 10075
        • Sadick Dermatology
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research Association
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
      • Portland, Oregon, United States, 97239
        • Knight Cancer Institute at Oregon Health and Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Clinical Research Center of the Carolinas
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center
    • Utah
      • South Jordan, Utah, United States, 84095
        • Jordan Valley Dermatology Center
    • Virginia
      • Burke, Virginia, United States, 22015
        • Pi Coor Clinical Research Llc
      • Richmond, Virginia, United States, 23226
        • Clinical Research Partners LLC
    • Washington
      • Spokane, Washington, United States, 99202
        • Dermatology Specialists of Spokane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group: Ruxolitinib
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.
Drug: ruxolitinib cream
ruxolitinib cream 1.5% will be applied twice daily as a thin film
Other Names:
  • INCB018424

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8
Time Frame: Baseline; 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8
Time Frame: Baseline; Week 8
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 8b is a validated instrument used to measure the severity of sleep disturbance. The PROMIS score includes 8 items, each of which asks the participant to rate the severity of their sleep disturbance on a daily basis on a severity scale of 1 to 5. The PROMIS total score is calculated as the sum of the 8 items and ranges from 8 to 40. A higher PROMIS score indicates more severe sleep disturbance. The baseline score was the 7-day average of nonmissing scores for the 6 days preceding a participant's Visit 1 and their response at Visit 1. Week 8 scores comprised the 7-day average of nonmissing scores for the 6 days preceding a participant's Visit 3 and their response at Visit 3. The average was not valid and was set to missing if scores were missing on 4 or more days. Change from baseline was calculated as the post-baseline value minus the baseline value.
Baseline; Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Actual)

January 22, 2025

Study Completion (Actual)

January 22, 2025

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 18424-902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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