
SPD 2026: Phase 3 Success for Lebrikizumab in Younger Pediatric AD Patients
Lawrence Eichenfield, MD, presented phase 3 results showing lebrikizumab boosts skin clearance, eases itch, and looks safe for infants through teens with moderate to severe atopic dermatitis.
The study enrolled patients ranging from 6 months to 17 years of age with moderate to severe AD in a randomized, placebo-controlled trial. Participants were randomized in a 2:1 ratio to receive either lebrikizumab or placebo. Recognizing the ethical considerations of pediatric research, all patients received background topical therapy—including topical corticosteroids or topical calcineurin inhibitors—following an initial run-in period, ensuring that no participant remained on placebo alone throughout the 16-week treatment period.
As Eichenfield noted, lebrikizumab produced clinically meaningful and statistically significant improvements across multiple efficacy endpoints. Approximately half of patients receiving lebrikizumab achieved Investigator's Global Assessment (IGA) scores of clear or almost clear skin by week 16, compared with roughly 15% of patients receiving placebo. Improvements were similarly robust for Eczema Area and Severity Index (EASI) outcomes. EASI-75 was achieved by 62.6% of patients treated with lebrikizumab versus just over 20% in the placebo group.
Higher thresholds of disease clearance also favored active treatment. More than one-third of patients receiving lebrikizumab achieved EASI-90 by week 16, compared with fewer than 12% of placebo-treated participants. Complete skin clearance (EASI-100) was observed in nearly 14% of patients receiving lebrikizumab, highlighting the potential for substantial disease control in a meaningful subset of pediatric patients. Pruritus outcomes also demonstrated significant benefit. Approximately 42% of younger children experienced clinically meaningful improvements in caregiver-reported scratching behavior, while roughly one-third of older children and adolescents achieved at least a 4-point improvement on the Worst Itch Numeric Rating Scale.
Eichenfield emphasized that the therapy's safety profile was favorable throughout the study, with accompanying improvements in quality-of-life measures further supporting its clinical benefit. Given that dupilumab is currently the only biologic approved for children younger than 12 years, these findings represent an important milestone for pediatric AD treatment. As a selective IL-13 inhibitor, lebrikizumab may soon offer clinicians an additional targeted biologic option across a broad pediatric age range, pending future regulatory review.
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