The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis

• Status: Not yet recruiting
• Trial end date: 2022-01-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.