Atopic DermatitisPhase 4MORPHEUSNCT05696392
The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
A Phase 4 study testing ruxolitinib cream in people with Atopic Dermatitis, run by Incyte Corporation at 30 sites in United States.
Trial summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- ruxolitinib cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 30 sitesUnited States
- Study dates
- 16 Mar 2023to 22 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Arlington Research Center
Arlington, Texas, 76011
Skin Care Research, Llc
Boca Raton, Florida, 33486
Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, 02215
Suny Downstate Health Sciences University
Brooklyn, New York, 11203
Pi Coor Clinical Research Llc
Burke, Virginia, 22015
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Specialists Research Indiana
Clarksville, Indiana, 47129
Driven Research Llc
Coral Gables, Florida, 33134
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Empire Dermatology
East Syracuse, New York, 13057
First Oc Dermatology
Fountain Valley, California, 92708
University of Florida Health Dermatology-Springhill
Gainesville, Florida, 32606
Skin Care Research, Llc Scr Hollywood
Hollywood, Florida, 33021
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, 46250
Ark Clinical Research
Long Beach, California, 90815
Skin Sciences Pllc
Louisville, Kentucky, 40217
Northeast Dermatology Associates
Methuen, Massachusetts, 01844
Ciocca Dermatology Pa
Miami, Florida, 33173
Essential Dermatology
Natick, Massachusetts, 01760
Sadick Dermatology
New York, New York, 10075
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Knight Cancer Institute At Oregon Health and Science University
Portland, Oregon, 97239
Clinical Research Partners Llc
Richmond, Virginia, 23226
Skin Search of Rochester
Rochester, New York, 14623
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Washington University School of Medicine Dermatology
St Louis, Missouri, 63110
Trueblue Clinical Research
Tampa, Florida, 33609
Gw Training Center
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis
- Being tested
- ruxolitinib cream
- Keywords
- ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinib creamDrug
Also called INCB018424
ruxolitinib cream 1.5% will be applied twice daily as a thin film
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group: Ruxolitinib | Experimental | ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film. Receives: Drug: ruxolitinib cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Week 8
Secondary outcomes (1)
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at 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.
Measured: Baseline; Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start16 Mar 2023
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Why it stopped: The study was terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696392
- Sponsor's protocol ID
- INCB 18424-902
- Acronym
- MORPHEUS
- Status last verified
- Dec 2025
- First submitted
- 13 Jan 2023
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
- ClinicalTrials.gov ID
- NCT05696392
- Acronym / sponsor ID
- MORPHEUS / INCB 18424-902
- Conditions
- Atopic Dermatitis
- Keywords
- ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to lack of enrollment.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group: Ruxolitinib | Experimental | Drug: ruxolitinib creamruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinib creamAlso: INCB018424ruxolitinib cream 1.5% will be applied twice daily as a thin film | Drug | Treatment Group: Ruxolitinib |
Primary outcome
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.
1 secondary outcome
Change From Baseline in PROMIS Sleep Disturbance - Short Form 8b Score (24-hour Recall) at Week 8
Time frame: Baseline; Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The purpose of this study is to evaluate the effects of ruxolitinib cream on adults with atopic dermatitis experiencing sleep disturbance. (MORPHEUS)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ruxolitinib cream in people with Atopic Dermatitis, run by Incyte Corporation at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Total Sleep Time (TST) as Measured by Ōura Ring Wearable Device at Week 8 (time frame: Baseline; Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.