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

Launched by ABBVIE · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called upadacitinib, which is being tested in combination with topical corticosteroids (creams or ointments applied to the skin) for treating moderate to severe atopic dermatitis (also known as eczema) in children aged 2 to 11 years in Japan. The goal of the study is to see how well this treatment works in reducing skin inflammation and itching, and to check if it is safe for young patients. Around 98 children will participate in the study, which includes a screening period followed by 12 weeks of treatment where some will receive the medication and others will get a placebo (a non-active pill), followed by up to 52 weeks of open-label treatment with upadacitinib.

To be eligible for the trial, children must have a certain level of atopic dermatitis severity and must have been experiencing symptoms for at least six months. They should also weigh at least 10 kg and have not responded well to other topical treatments recently. Participants will visit the clinic regularly for assessments, blood tests, and to monitor any side effects. It's important to note that this trial may involve more frequent visits and treatment than what they would normally receive for their skin condition.

Gender

ALL

Eligibility 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:
• • 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.