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

Incyte

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ruxolitinib cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04839380

INCB 18424-901

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Treatment Group : Ruxolitinib

Experimental group

Description:

ruxolitinib cream 1.5% will be applied twice daily as a thin film.

Treatment:

Drug: ruxolitinib cream