Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

AD Sleep Disturbance

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

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

Details

Full study 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)
Protocol number OCR43865
ClinicalTrials.gov ID NCT05696392
Phase Phase 4

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.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Marjorie Montanez-Wiscovich
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.