An Open-Label, Single-Arm, Phase 4 Study of Ruxolitinib Cream in Adults With Atopic Dermatitis Experiencing Sleep Disturbance in the United States (MORPHEUS)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
First Oc Dermatology
RECRUITING
Fountain Valley
Ark Clinical Research
RECRUITING
Long Beach
Washington, D.c.
Gw Training Center
COMPLETED
Washington
Florida
Skin Care Research, Llc
RECRUITING
Boca Raton
Trueblue Clinical Research
RECRUITING
Brandon
Driven Research Llc
COMPLETED
Coral Gables
University of Florida Health Dermatology-Springhill
COMPLETED
Gainesville
Skin Care Research, Llc Scr Hollywood
RECRUITING
Hollywood
Ciocca Dermatology Pa
COMPLETED
Miami
Indiana
Dermatology Specialists Research Indiana
RECRUITING
Clarksville
Dawes Fretzin Clinical Research Group Llc
RECRUITING
Indianapolis
Kentucky
Skin Sciences Pllc
COMPLETED
Louisville
Massachusetts
Beth Israel Deaconess Medical Center (Bidmc)
COMPLETED
Boston
Northeast Dermatology Associates
COMPLETED
Methuen
Essential Dermatology
COMPLETED
Natick
Missouri
Washington University School of Medicine Dermatology
COMPLETED
Saint Louis
New York
Suny Downstate Health Sciences University
RECRUITING
Brooklyn
Empire Dermatology
RECRUITING
East Syracuse
Sadick Dermatology
RECRUITING
New York
Skin Search of Rochester
RECRUITING
Rochester
Ohio
Ohio Pediatric Research Association
RECRUITING
Dayton
Oregon
Knight Cancer Institute At Oregon Health and Science University
COMPLETED
Portland
Oregon Dermatology and Research Center
RECRUITING
Portland
Pennsylvania
University of Pittsburgh
COMPLETED
Pittsburgh
South Carolina
Clinical Research Center of the Carolinas
COMPLETED
Charleston
Texas
Arlington Research Center
COMPLETED
Arlington
Utah
Jordan Valley Dermatology Center
COMPLETED
South Jordan
Virginia
Pi Coor Clinical Research Llc
NOT_YET_RECRUITING
Burke
Clinical Research Partners Llc
COMPLETED
Richmond
Washington
Dermatology Specialists of Spokane
RECRUITING
Spokane
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date:2023-03-16
Estimated Completion Date:2025-02-05
Participants
Target number of participants:100
Treatments
Experimental: Treatment Group: Ruxolitinib
ruxolitinib cream 1.5% will be applied twice daily (BID) as a thin film.