The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis (SCRATCH-AD)

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    48
  • sponsor
    Incyte Corporation
Updated on 29 July 2022

Summary

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

Details
Condition Atopic Dermatitis
Treatment Ruxolitinib cream
Clinical Study IdentifierNCT04839380
SponsorIncyte Corporation
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has clinically confirmed diagnosis of active AD for at least a 6-months
Participant has chronic pruritus related to AD for at least 3 months
Participant has an overall BSA (excluding palms, soles, scalp, genitals, and folds) affected by AD of 1%-20% on Day 1
Participant has an IGA score of at least 2 on Day 1
Participant has a single PP-NRS score ≥ 4 in the 24-hour period prior to the screening visit
Willingness to avoid pregnancy or fathering children
Participant must be willing to comply with all study procedures and restrictions including discontinuation of all current therapies for AD and pruritus (unless otherwise specified), and must be available for the duration of the study

Exclusion Criteria

Female participnat who is breastfeeding, pregnant, or planning to become pregnant during the study
Participant had significant flares or unstable course in AD
Participant has clinically infected AD or has used antibiotics (systemic or topical) for their infected AD within 2 weeks prior to the run-in period
Participant has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments
Participant has any clinically significant medical condition or physical/laboratory/vital sign abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with interpretation of study results
Participant has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the run-in period
Participant is unlikely, in the opinion of the investigator, to be compliant with study procedures and requirements
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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