Atopic Dermatitis
Conditions
Interventions
Placebo Comparator: Placebo / Upadacitinib + Topical Corticosteroids (TCS)
Participants will receive placebo orally once a day (QD) in combination with TCS for 12 weeks in the double-blind treatment p
Sponsors
Fujimura Kimino
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - A minimum weight of 10 kg and weight and height -2.0 SD for their age according to Japanese standard growth charts at the Baseline visit. - Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline. - Eczema Area and Severity Index (EASI) score 16; validated Investigator Global Assessment 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 daily WIS or WSI-NRS 4. - Participant has applied a topical, additive-free, bland emollient or moisturizer twice daily for at least 7 days before the Baseline visit. - Documented history (within 6 months of the Baseline visit) of inadequate response or intolerance to topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) or a systemic immunomodulating therapy, or medical inadvisability of available systemic therapy (e.g., because of important side effects or safety risks).
Exclusion criteria
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 the Baseline visit or that would interfere with the appropriate assessment of AD lesions. - Participants that have used topical treatments for AD (except for topical emollient or moisturizer treatments) including but not limited to TCS, TCI, or topical PDE-4 inhibitors, within 7 days of the Baseline visit or any the following prohibited AD treatments within the specified timeframes below prior to the Baseline visit: -- Systemic therapy for AD, including but not limited to corticosteroids and cyclosporine, 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 sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 at Week 12 - Number of Participants With Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of participants achieving validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) 0/1 with a reduction from Baseline of 2 points at Week 12 - Percentage of participants achieving an improved (reduced) weekly average Worst Itch Scale (WIS) score of 4 from Baseline at Week 12 for participants equal or greater than 6 years old with a weekly average WIS of 4 at Baseline - Percentage of participants achieving an improved (reduced) weekly average Worst Scratch/Itch numerical rating scale (WIS-NRS) score of 4 from Baseline at Week 12 for participants less than 6 years old with a weekly average WIS of 4 at Baseline | — |
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed