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

Atopic Dermatitis Clinical Trial

— MORPHEUS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696392
• Other study ID #: INCB 18424-902
• Status: Recruiting
• Phase: Phase 4
• Start date: March 16, 2023
• Est. completion date: September 27, 2024

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dyssomnias
• Eczema
• Parasomnias

Intervention

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

Locations

Country	Name	City	State
United States	Arlington Research Center	Arlington	Texas
United States	Northeast Dermatology Associates	Beverly	Massachusetts
United States	Skin Care Research, Llc	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center (Bidmc)	Boston	Massachusetts
United States	Trueblue Clinical Research	Brandon	Florida
United States	Suny Downstate Health Sciences University	Brooklyn	New York
United States	Pi Coor Clinical Research Llc	Burke	Virginia
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Dermatology Specialists Research Indiana	Clarksville	Indiana
United States	Driven Research Llc	Coral Gables	Florida
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Empire Dermatology	East Syracuse	New York
United States	First Oc Dermatology	Fountain Valley	California
United States	University of Florida Health Dermatology-Springhill	Gainesville	Florida
United States	Skin Care Research, Llc Scr Hollywood	Hollywood	Florida
United States	Dawes Fretzin Clinical Research Group Llc	Indianapolis	Indiana
United States	Ark Clinical Research	Long Beach	California
United States	Skin Sciences Pllc	Louisville	Kentucky
United States	Ciocca Dermatology Pa	Miami	Florida
United States	Essential Dermatology	Natick	Massachusetts
United States	Sadick Dermatology	New York	New York
United States	University of Pittsburgh Medical Center Upmc Dermatology Clinic Oakland Falk Medical Building	Pittsburgh	Pennsylvania
United States	Knight Cancer Institute At Oregon Health and Science University	Portland	Oregon
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Clinical Research Partners Llc	Richmond	Virginia
United States	Skin Search of Rochester	Rochester	New York
United States	Washington University School of Medicine Dermatology	Saint Louis	Missouri
United States	Jordan Valley Dermatology Center	South Jordan	Utah
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	The Gw Medical Faculty Associates	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Oura Ring wearable device.	Week 8
Secondary	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