Lebrikizumab proves benefit in phase 3 pediatric atopic dermatitis trial

Eli Lilly and Company announced positive topline results from the phase 3 ADorable-1 trial (NCT05559359) evaluating lebrikizumab (Ebglyss) in pediatric patients with moderate to severe atopic dermatitis, including infants and children as young as 6 months.

Announced on March 16, 2026, the interleukin (IL)–13 inhibitor, which is already approved for adults and adolescents with atopic dermatitis, met both co–primary end points at week 16, with Lilly indicating it plans to submit the data to US and global regulators for a potential label expansion.¹

“Despite the high prevalence of moderate-to-severe atopic dermatitis in infants and young children, they have fewer approved treatment options than adults and adolescents,” said study investigator Amy Paller, MD, chair of the Department of Dermatology at Northwestern University. “The topline results from ADorable-1 offer hope for these young patients, delivering near-complete skin clearance and significant itch relief with a highly selective medicine that targets the underlying inflammation that drives this chronic disease.”

Phase 3 ADorable-1 Results in Pediatric Atopic Dermatitis

ADorable-1 was a randomized, double-blind, placebo-controlled trial enrolling 363 pediatric patients with moderate to severe atopic dermatitis. Participants received either placebo or weight-based lebrikizumab dosing. The study had co–primary end points of at least a 75% reduction in Eczema Area and Severity Index (EASI-75) from baseline and clear or almost clear skin, which was defined as Investigator's Global Assessment score of 0 or 1 or lower with at least a 2-point reduction from baseline, at week 16. Topical corticosteroids were required beginning 2 weeks before randomization and continued throughout the 16-week study, though they could be tapered or discontinued once patients achieved an

Both co–primary end points at week 16 were met. In the lebrikizumab arm, 63% of patients achieved EASI-75 compared with 22% in the placebo group. Clear or almost clear skin was achieved by 44% of lebrikizumab-treated patients, compared with 15% on placebo.¹

Key secondary end points further supported the primary findings. Near-complete skin clearance (EASI-90) was achieved by 39% of lebrikizumab-treated patients compared with 11% on placebo. Among patients 6 years and older with a baseline Pruritus Numerical Rating Scale score of 4 or higher, 35% of those receiving lebrikizumab achieved clinically meaningful itch reduction (at least a 4-point improvement), compared with 6% on placebo.¹

The safety profile was consistent with data from adult and adolescent studies, with no new safety signals identified. Upper respiratory tract infections and nasopharyngitis were the most common adverse events, each occurring in 5% or more of participants, with no numerical imbalance between arms. Injection site reactions were reported at similar rates in both groups, and no injection site pain was reported.¹

Pediatric Atopic Dermatitis: An Underserved Population

According to the American Academy of Pediatrics, atopic dermatitis affects 20% to 25% of children and has a significant impact on quality of life for patients and families. The disease is disproportionately a pediatric condition, and an estimated 9.6 million children in the United States are affected, with approximately one-third having moderate to severe disease.¹ Despite this prevalence, approved biologic options in younger age groups have historically lagged behind those available for adults and adolescents, leaving a meaningful gap in children who experience chronic refractory disease, which can significantly disrupt sleep, development, and daily functioning for both patients and caregivers.

Lebrikizumab selectively inhibits IL-13, a primary cytokine driving the type 2 inflammatory cycle in atopic dermatitis, producing skin barrier dysfunction, itch, skin thickening, and increased susceptibility to infection. According to Eli Lilly and Company, the high binding affinity and slow dissociation rate are pharmacologic properties that differentiate it mechanistically from dupilumab, which targets the shared IL-4/IL-13 receptor subunit. However, head-to-head pediatric comparative data across agents are not available.

The company noted the ADorable clinical program is ongoing, with full results from ADorable-1 and data from ADorable-2 (NCT05559359), a 52-week extension study enrolling patients from ADorable-1, are expected later in 2026.

References

1. Lilly’s Ebglyss (lebrikizumab-lbkz) is the first and only selective IL-13 inhibitor to deliver positive phase 3 outcomes in patients aged six months to 18 years with moderate-to-severe atopic dermatitis. News release. Eli Lilly and Company. March 16, 2026. Accessed March 16, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-first-and-only-selective-il-13

2. Schoch JJ, Anderson KR, Jones AE, Tollefson MM; Section on Dermatology. Atopic dermatitis: update on skin-directed management: clinical report. Pediatrics. 2025;155(6):e2025071812. doi:10.1542/peds.2025-071812