A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.

Key facts

Study ID: NCT06238817
Run by: Incyte Corporation
People needed: 241
Starts: 2024-04-26
Expected to finish: 2025-10-17
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged ≥ 18 years at screening (Note: Legal adult age for Korea is ≥ 19 years).
Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.
AD duration of at least 2 years.
IGA score of 3 at screening and Day 1.
EASI score > 7 at screening and Day 1.
Itch NRS score ≥ 4 at Day 1, defined as the average of the 7 days directly before Day 1, with Itch NRS values available for at least 4 of the 7 days.
%BSA (excluding the scalp) with AD involvement of at least 10% and up to 20% at screening and Day 1.
DLQI score > 10 at screening and Day 1.
Documented recent history (within 12 months before the screening visit) of inadequate response, intolerance, or contraindication to TCSs and TCIs.
Agree to discontinue all agents used to treat AD from screening through the final follow up visit, except as outlined in the protocol.
Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.

You may not qualify if…

Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
Concurrent conditions and history of other diseases as follows:
Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Day 1.
Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox) within 1 week before Day 1.
Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds.
Other types of eczema within the 6 months prior to screening. Note: Seborrheic dermatitis on the scalp is allowed, as the scalp will not be treated with study cream.
Current or history of hepatitis B or C virus infection.
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Any of the following clinical laboratory test results at screening:
Hemoglobin < 10 g/dL.
Liver function tests:
AST or ALT ≥ 2 × ULN.
Alkaline phosphatase > 1.5 × ULN.
Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) with the exception of Gilbert's disease.
Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation).
Positive serology test results for HIV antibody.
Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant.
Use of any of the following treatments within the indicated washout period before Day 1:
5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologic agents with washout periods longer than 12 weeks (eg, rituximab), consult the medical monitor.
4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate or tacrolimus).
2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4 inhibitors.
2 weeks: immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
Note: COVID-19 vaccination is allowed.

Where it is running

First Oc Dermatology — Fountain Valley, California, United States
Center For Dermatology Cosmetic and Laser Surgery — Fremont, California, United States
Medderm Associates, Inc — San Diego, California, United States
Encore Medical Research, Llc Hollywood — Hollywood, Florida, United States
Entrust Clinical Research — Miami, Florida, United States
Lane Dermatology and Dermatologic Surgery — Columbus, Georgia, United States
Marietta Dermatology the Skin Cancer Center Marietta — Marietta, Georgia, United States
Arlington Dermatology — Rolling Meadows, Illinois, United States
Northshore University Healthsystem — Skokie, Illinois, United States
Oakland Hills Dermatology Pc — Auburn Hills, Michigan, United States
Revival Research Institute, Llc Troy — Troy, Michigan, United States
Best Skin Research — Camp Hill, Pennsylvania, United States
International Clinical Research Tennessee Llc — Murfreesboro, Tennessee, United States
Center For Clinical Studies Webster — Houston, Texas, United States
Texas Dermatology Research Center — Plano, Texas, United States
Rainey and Finklea Dermatology — San Antonio, Texas, United States
North Sound Dermatology — Mill Creek, Washington, United States
Premier Specialists Pty Ltd — Kogarah, New South Wales, Australia
Australian Clinical Research Network — Maroubra, New South Wales, Australia
Veracity Clinical Research — Woolloongabba, Queensland, Australia
Clinical Trials Sa — Campbelltown, South Australia, Australia
Skin Health Institute Inc. — Carlton, Victoria, Australia
Paratus Clinical Research, Woden — Phillip, Australia
Ulb Hospital Erasme — Brussels, Belgium
Lynn Institute of the Ozarks — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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