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

Inclusion Criteria:

• 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 beforeDay 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% atscreening and Day 1.

• DLQI score > 10 at screening and Day 1.

• Documented recent history (within 12 months before the screening visit) ofinadequate response, intolerance, or contraindication to TCSs and TCIs.

• Agree to discontinue all agents used to treat AD from screening through the finalfollow up visit, except as outlined in the protocol.

• Willingness to avoid pregnancy or fathering children based on the criteria asoutlined in the protocol.

Exclusion Criteria:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) asdetermined 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 weeksbefore 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 asNetherton syndrome), pigmentation, or extensive scarring that, in the opinionof the investigator, may interfere with the evaluation of AD lesions orcompromise participant safety.

• Presence of AD lesions only on the hands or feet without prior history ofinvolvement of other classic areas of involvement such as the face or theflexural folds.

• Other types of eczema within the 6 months prior to screening. Note: Seborrheicdermatitis on the scalp is allowed, as the scalp will not be treated with studycream.

• Current or history of hepatitis B or C virus infection.

• Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study cream and attending required study visits; pose asignificant 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 ifbilirubin is fractionated and direct bilirubin < 35%) with the exceptionof Gilbert's disease.

• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the ChronicKidney Disease Epidemiology Collaboration equation).

• Positive serology test results for HIV antibody.

• Any other clinically significant laboratory result that, in the opinion of theinvestigator, poses a significant risk to the participant.

• Use of any of the following treatments within the indicated washout period beforeDay 1:

• 5 half-lives or 12 weeks, whichever is longer: biologic agents. For biologicagents with washout periods longer than 12 weeks (eg, rituximab), consult themedical monitor.

• 4 weeks: systemic corticosteroids or adrenocorticotropic hormone analogs,cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive (eg, JAK inhibitors) or immunomodulating agents (eg, mycophenolate ortacrolimus).

• 2 weeks or 5 half-lives, whichever is longer - strong systemic CYP3A4inhibitors.

• 2 weeks: immunizations with live-attenuated vaccines; sedating antihistaminesunless on a long-term stable regimen (nonsedating antihistamines arepermitted).

Note: COVID-19 vaccination is allowed.

• 1 week: use of other topical treatments for AD, other than bland emollients (eg, Aveeno creams, ointments, sprays, soap substitutes), such as antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap.

Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.

• History of treatment failure with any systemic or topical JAK inhibitor (eg,ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) for AD or anyother inflammatory condition.

• Ultraviolet light therapy or prolonged exposure to natural or artificial sources ofUV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baselinevisit and/or intention to have such exposure during the study that is thought by theinvestigator to potentially impact the participant's AD.

• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)before baseline with another investigational medication or current enrollment inanother investigational drug protocol.

• In the opinion of the investigator, are unable or unlikely to comply with theadministration schedule, study evaluations, and procedures (eg, eDiary compliance).

Other protocol-defined Inclusion/Exclusion Criteria may apply.