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

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.