Clinical trial NCT05696392: The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: ruoltitinib
atopic dermatitis
sleep distubance
itch
Opzelura
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Total Sleep Time (TST)
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in PROMIS Sleep Disturbance
timeFrame: Week 8
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Washington
country: United States
facility: Gw Training Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Skin Care Research, Llc
state: Florida
city: Coral Gables
country: United States
facility: Driven Research Llc
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Dermatology-Springhill
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, Llc Scr Hollywood
state: Florida
city: Miami
country: United States
facility: Ciocca Dermatology Pa
state: Florida
city: Tampa
country: United States
facility: Trueblue Clinical Research
state: Florida
city: Clarksville
country: United States
facility: Dermatology Specialists Research Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group Llc
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences Pllc
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (Bidmc)
state: Massachusetts
city: Methuen
country: United States
facility: Northeast Dermatology Associates
state: Massachusetts
city: Natick
country: United States
facility: Essential Dermatology
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine Dermatology
state: Missouri
city: Brooklyn
country: United States
facility: Suny Downstate Health Sciences University
state: New York
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: New York
country: United States
facility: Sadick Dermatology
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Knight Cancer Institute At Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Burke
country: United States
facility: Pi Coor Clinical Research Llc
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners Llc
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
Study officials:
References: