A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

Inclusion Criteria:

• Aged 6 to < 18 years at the VC Day 1 visit.

• Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria.

• AD duration of at least 3 months for 6 to 11 year olds and at least 2 years for 12to < 18 year olds (participant/parent/guardian may verbally report signs andsymptoms of AD).

• EASI score > 7 at the screening and VC Day 1 visits.

• IGA score of 3 at the screening and VC Day 1 visits.

• Percent BSA (excluding the scalp) with AD involvement of at least 3% and up to 20%at the screening and VC Day 1 visits.

• Itch NRS or WI NRS score ≥ 4 at the screening and VC Day 1 visits, defined as theaverage of the 7 days directly before the VC/Day 1 visit, with Itch NRS or WI NRSvalues available for at least 4 of the 7 days.

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

• Inadequate response:

• For TCSs: Inability of a given TCS to induce and maintain remission or tocontain the AD severity at an acceptable level (comparable to an IGA scoreof 0 [clear] or 1 [almost clear]) despite treatment for 28 days or for themaximum duration recommended by the product prescribing information (eg, 14 days for superpotent TCSs), whichever is shorter and

• For TCIs: Inability of a given TCI to induce and maintain remission or tocontain the AD severity at an acceptable level (comparable to an IGA scoreof 0 [clear] or 1 [almost clear]) despite treatment according to theproduct prescribing information.

Note: Documented (within 12 months before the screening visit) systemic treatment for AD (eg, oral corticosteroids, cyclosporine, methotrexate, azathioprine, mycophenolate mofetil) or phototherapy or photo(chemo)therapy can also be considered as a surrogate for inadequate response to TCSs and TCIs.

• Intolerance: Clinically relevant side effects, safety risks, or skin tolerability issues that outweigh the potential treatment benefits and are the reason why a topical treatment could not be restarted or continued.

Note: Documented history (more than 12 months prior to the screening visit) of clinically significant adverse reactions with use of TCSs and/or TCIs that in the opinion of the investigator outweigh the benefits of restarting treatment would also be considered as evidence of intolerance.

• Contraindication: As defined in the product prescribing information.

• Agreement by participants and guardians to discontinue all agents used by theparticipant to treat AD from the screening visit through the final safety follow-upvisit, except as outlined in the protocol.

• For sexually active participants, willingness to take appropriate contraceptivemeasures to avoid pregnancy or fathering a child for the duration of studyparticipation with the exception of prepubescent participants.

Note: Female participants who have reached menarche must have a negative urine pregnancy test at the screening and baseline visits before the first application of study cream at baseline. They must also take appropriate precautions to avoid pregnancy from the screening visit through the safety follow-up visit.

• Ability to comprehend and willingness to sign an ICF or written informed consent of the parent(s) or legal guardian and a verbal or written assent from the participant when possible.

Note: A signed written ICF must be obtained for inclusion; see protocol.

Exclusion Criteria:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) asdetermined by the investigator in the 4 weeks prior to the VC Day 1 visit.

• 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 the VC Day 1 visit.

• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex,herpes zoster, chickenpox) within 1 week before the VC Day 1 visit.

• 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:

• Absolute neutrophil count < 1000/μL.

• Platelet count < 100,000/μL.

• AST or ALT ≥ 2 × ULN.

• Alkaline phosphatase > 1.5 × ULN.

• Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable ifbilirubin isfractionated and direct bilirubin < 35%) with the exception ofGilbert disease.

• Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using theModification of Diet in Renal Disease 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 beforethe VC Day 1 visit:

• 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 (eg, mycophenolate or tacrolimus)agents.

• 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.

• Pregnant or lactating participants or those considering pregnancy during the periodof their study participation.

• Living with anyone participating in any current Incyte-sponsored ruxolitinib creamstudy.

• Known allergy or reaction to any component of the study cream formulation.

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

• Committed to a mental health institution by virtue of an order issued either by thejudicial or the administrative authorities.

• Employees of the sponsor, sponsor delegates (eg, contract research organizations),or investigators or are otherwise dependents of them.

• The following participants are excluded in France: vulnerable populations accordingto article L.1121-6 of the French Public Health Code and adults under legalprotection, or who are unable to express their consent per article L.1121-8 of theFrench Public Health Code, not affiliated to a social security per articleL.1121-8-1 of the French Public Health Code.

• In the EU, participants considered incapacitated (according to CTR Article 31).