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

NCT ID: NCT04839380

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-11-18

Brief Summary

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

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group : Ruxolitinib

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

Group Type: EXPERIMENTAL

ruxolitinib cream

Intervention Type: DRUG

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

Interventions

ruxolitinib cream

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

Intervention Type: DRUG

Other Intervention Names

INCB018424

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Innovaderm Research Inc.

Montreal, Quebec, Canada

Innovoderm Research

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 18424-901

Identifier Type: -

Identifier Source: org_study_id