Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis

Inclusion Criteria:

• A minimum weight of 10 kg and weight and height ≥ -2.0 SD for their age according toJapanese standard growth charts at the Baseline visit.

• Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset ofsymptoms at least 6 months prior to Baseline.

• Eczema Area and Severity Index (EASI) score ≥ 16; validated Investigator GlobalAssessment scale for Atopic Dermatitis (vIGA-AD) score ≥ 3; ≥ 10% body surface area (BSA) of AD involvement at the Baseline visit; and Baseline weekly average of dailyWIS or WSI-NRS ≥ 4.

• Participant has applied a topical, additive-free, bland emollient or moisturizertwice daily for at least 7 days before the Baseline visit.

• Documented history (within 6 months of the Baseline visit) of inadequate response orintolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of availablesystemic therapy (e.g., because of important side effects or safety risks).

Exclusion Criteria:

• Participants that have current and/or history of other active skin diseases (e.g.,psoriasis or Netherton syndrome or lupus erythematosus) or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of theBaseline visit or that would interfere with the appropriate assessment of ADlesions.

• Participants that have used topical treatments for AD (except for topical emollientor moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4inhibitors, within 7 days of the Baseline visit or any the following prohibited ADtreatments within the specified timeframes below prior to the Baseline visit:

• Systemic therapy for AD, including but not limited to corticosteroids andcyclosporine, within 4 weeks;

• Targeted biologic treatments within 5 half-lives (if known) or within 12 weeks,whichever is longer;

• Phototherapy treatment, laser therapy, tanning booth use, or extended sunexposure that could affect disease severity or interfere with diseaseassessments within 4 weeks.