Dermatitis
The purpose of this study is to evaluate the effects of ruxolitinib cream on adults with atopic dermatitis experiencing sleep disturbance.
Incyte Study ID:
INCB 18424-902
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
The purpose of the study is to evaluate the effect of ruxolitinib cream on sleep disturbances with participants with Atopic Dermatitis.
Clinical Study Summary

MEDICAL CONDITION(S)

PRODUCT

COLLABORATORS
N/A

DATE
Mar 2023 - Jan 2025

TYPE
Interventional

PHASE
Phase 4

SEX
Female & Male

AGE
18+ years

ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
KNIGHT CANCER INSTITUTE AT OREGON HEALTH AND SCIENCE UNIVERSITY
PORTLAND, OR, US, 97239
Name
FIRST OC DERMATOLOGY
FOUNTAIN VALLEY, CA, US, 92708
Name
GW TRAINING CENTER
WASHINGTON, DC, US, 20037
Name
SUNY DOWNSTATE HEALTH SCIENCES UNIVERSITY
BROOKLYN, NY, US, 11203
Name
ARLINGTON RESEARCH CENTER
ARLINGTON, TX, US, 76011
Name
DAWES FRETZIN CLINICAL RESEARCH GROUP LLC
INDIANAPOLIS, IN, US, 46250
Key Inclusion and Exclusion 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).
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.
Protocol Summary
Incyte Study ID:
INCB 18424-902
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
47
Primary Outcome
Open
Change from baseline in Total Sleep Time (TST)
Timeframe: Week 8
Secondary Outcome
Open
Change from baseline in PROMIS Sleep Disturbance
Timeframe: Week 8