Status:
COMPLETED
The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis
Lead Sponsor:
Incyte Corporation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the effect of ruxolitinib cream on itch in participants with Atopic Dermatitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04839380
Start Date
October 12 2021
End Date
November 18 2022
Last Update
October 31 2023
Active Locations (2)
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1
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
2
Innovoderm Research
Montreal, Quebec, Canada, H2K 4LS