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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: ruxolitinib cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group: Ruxolitinib<br>ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film. | Drug: ruxolitinib cream<br>* ruxolitinib cream 1.5% will be applied twice daily as a thin film<br>* Other names: INCB018424;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Total Sleep Time (TST) | Total sleep time (TST) is the total amount of time spent during a planned sleep episode. TST will be measured by the Ōura Ring wearable device. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PROMIS Sleep Disturbance | PROMIS sleep disturbance will be measured by a questionnaire which includes a 5-point scale with a range in score from 8 to 40, with higher scores indicating greater severity of sleep disturbance. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ruoltitinib, atopic dermatitis, sleep distubance, itch, Opzelura