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

Incyte

Status and phase: Enrolling; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: ruxolitinib cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05696392

INCB 18424-902

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment Group: Ruxolitinib

Experimental group

Description:

ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.

Treatment:

Drug: ruxolitinib cream