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The study was terminated due to lack of enrollment.
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The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group: Ruxolitinib | Experimental | ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ruxolitinib cream | Drug | ruxolitinib cream 1.5% will be applied twice daily as a thin film |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Oc Dermatology | Fountain Valley | California | 92708 | United States | ||
| Ark Clinical Research |
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| Label | URL |
|---|---|
| The purpose of this study is to evaluate the effects of ruxolitinib cream on adults with atopic dermatitis experiencing sleep disturbance. (MORPHEUS) | View source |
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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.
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
This study was conducted at 17 study centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2022 | Dec 3, 2025 |
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| Baseline; Week 8 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Population: all participants who had no important protocol deviations. Participants must have had ≥4 nights worth of sleep data in order for the average to have been calculated; otherwise, it was set to missing. The average was based on non-missing nights of sleep data. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | hours | Baseline; Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent-to-Treat (ITT) Population: all participants who enrolled in the study. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Week 8 |
|
up to 12 weeks
Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area. | 0 | 47 | 0 | 47 | 7 | 47 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
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.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2025 | Dec 3, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Unknown or Not Reported |
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| Not Reported |
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| Captured as "Other" in Database |
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| White |
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