The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Has clinically confirmed diagnosis of active AD according to Hanifin and Rajka (1980) criteria.

• Has at least a 2-year history of AD (information obtained from medical chart, participant's physician, or directly from the participant).

• Has an overall BSA affected by AD of 3%-20% (excluding scalp) at the screening and baseline visits.

• Has an IGA score ≥ 2 at the screening and baseline visits.

• Has an Itch NRS score ≥ 4 at the screening and baseline visits.

• Willing to complete the once-daily Itch NRS (24-hour recall period) entries at approximately the same time each day during the study.

• Agrees to maintain a regular sleep schedule during the study period.

• Willing and able to follow required study procedures for measuring sleep for the duration of the study.

Exclusion Criteria:

• Currently using a wearable or other device for monitoring sleep patterns and unwilling to discontinue its use during the study.

• Currently has a schedule that includes nighttime work shifts.

• Has had significant flares or unstable course in AD (ie, condition worsened significantly or required significant change in medications, as per medical judgment) in the previous 4 weeks before screening (information obtained from medical chart, participant's physician, or directly from the participant).

• Has received any ultraviolet B phototherapy (including tanning beds) or excimer laser within 4 weeks prior to the screening period.

• Has had psoralen plus ultraviolet A treatment within 4 weeks prior to the screening period.

• Has received a nonbiological investigational product or device within 4 weeks prior to the screening period, or is currently enrolled in another investigational drug study.

• Has received treatment with JAK inhibitors (systemic or topical) within 4 weeks prior to the screening period.

• Has had prior treatment with a JAK inhibitor that was discontinued for safety reasons or tolerance problems.

• Has a known or suspected allergy to ruxolitinib or any component of the study drug.