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

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05696392

Collaborator

(none)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: ruxolitinib cream	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group: Ruxolitinib ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.	Drug: ruxolitinib cream ruxolitinib cream 1.5% will be applied twice daily as a thin film Other Names: INCB018424

Arm

Intervention/Treatment

Experimental: Treatment Group: Ruxolitinib

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

Drug: ruxolitinib cream

ruxolitinib cream 1.5% will be applied twice daily as a thin film

Other Names:

INCB018424

Outcome Measures

Primary Outcome Measures

Change from baseline in Total Sleep Time (TST) [Week 8]
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.

Secondary Outcome Measures

Change from baseline in PROMIS Sleep Disturbance [Week 8]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.