Phase 3 ADorable-1 Data Support Lebrikizumab for Children With AD

Positive top-line findings from the phase 3 ADorable-1 study (NCT05559359) suggest that the IL-13 inhibitor lebrikizumab-lbkz (Ebglyss; Eli Lilly and Company) may offer an effective targeted treatment option for children with moderate to severe atopic dermatitis (AD), a population that continues to face limited systemic therapy options.¹

In results announced by Eli Lilly and Company, the biologic met both primary and key secondary end points at week 16 in pediatric patients, demonstrating improvements in disease severity, skin clearance, and itch reduction. The company indicated that it plans to submit the data to US and global regulators to support a potential label expansion for younger patients.

Study Design and End Points

ADorable-1 is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of lebrikizumab in infants and children with moderate to severe AD, including patients as young as 6 months.

The study enrolled 363 participants who were randomly assigned to receive placebo or weight-based dosing of lebrikizumab. All patients used topical corticosteroids beginning 2 weeks before randomization and continuing throughout the 16-week study period. Once participants achieved an Investigator Global Assessment (IGA) score of 2 or lower, topical corticosteroids could be reduced or discontinued.

The coprimary end points were:

• EASI 75: At least a 75% reduction in the Eczema Area and Severity Index from baseline
• IGA 0 or 1: Clear or almost clear skin with a reduction of at least 2 points from baseline

Key secondary end points included EASI 90 (near-complete disease clearance) and improvement in itch severity measured by the Pruritus Numeric Rating Scale (NRS).

Clinically Meaningful Improvements

At week 16, patients treated with lebrikizumab showed markedly higher response rates compared with placebo across all measured outcomes.

Approximately 63% of patients receiving lebrikizumab achieved EASI 75 compared with 22% in the placebo group. Similarly, 44% of treated patients reached IGA 0 or 1 vs 15% with placebo.

Higher thresholds of improvement also favored the biologic. EASI 90 was achieved in 39% of patients receiving lebrikizumab compared with 11% of those receiving placebo.

Pruritus reduction, a critical outcome in pediatric AD, also improved substantially. Among children 6 years and older with baseline itch scores of at least 4, 35% experienced an improvement of at least 4 points on the Pruritus NRS compared with 6% in the placebo arm.

“These top-line results offer hope for young patients,” said Amy Paller, MD, chair of the Department of Dermatology at Northwestern University in Chicago, Illinois, and an investigator in the ADorable program. “Despite the high prevalence of moderate to severe [AD] in infants and young children, they have fewer approved treatment options than adults and adolescents. The findings show near-complete skin clearance and significant itch relief with a highly selective medicine that targets the underlying inflammation driving this chronic disease.”

Targeting IL-13–Driven Inflammation

Lebrikizumab is a monoclonal antibody designed to selectively inhibit IL-13 signaling with high binding affinity and a slow dissociation rate. IL-13 plays a central role in the type 2 inflammatory cascade that characterizes AD. The cytokine contributes to epidermal barrier dysfunction, chronic pruritus, lichenification, and increased susceptibility to infection.

By targeting IL-13, the therapy aims to interrupt this inflammatory cycle while allowing for more precise immune modulation compared with broader immunosuppressive strategies.

Safety Profile Consistent With Earlier Studies

Safety findings in ADorable-1 were consistent with the known profile of lebrikizumab in adult and adolescent populations. No new safety signals were reported.

The most common adverse events—occurring in at least 5% of participants—were upper respiratory tract infections and nasopharyngitis, with similar frequencies between treatment groups. Injection site reactions were reported at comparable rates in the lebrikizumab and placebo arms, and no injection site pain was reported.

A Substantial Pediatric Burden

AD affects an estimated 9.6 million children in the United States, with approximately one-third experiencing moderate to severe disease. In these patients, chronic inflammation, impaired skin barrier function, and persistent pruritus can significantly disrupt sleep, school performance, and quality of life.²

“Children with moderate to severe [AD] often endure relentless skin flares, itch, and discomfort that can disrupt play, school, and daily life for patients and caregivers,” said Adrienne Brown, executive vice president and president of Lilly Immunology. “[Lebrikizumab] has already changed what’s possible for adults and adolescents, delivering durable results that help patients flare less with the option of monthly maintenance dosing. Now, these data show [lebrikizumab] also provided disease control in pediatric patients, a critical milestone that, if approved, could bring profound relief to these patients and their families.”

Next Steps for the ADorable Program

The pediatric development program for lebrikizumab remains ongoing. Eli Lilly noted that additional analyses from ADorable-1 and results from ADorable-2 (NCT05735483), a 52-week extension study evaluating long-term outcomes, are expected later this year.

If regulatory submissions lead to approval, the therapy could represent a new targeted biologic option for infants and young children with moderate to severe AD—an age group where therapeutic choices remain limited and disease burden can be substantial for both patients and families.

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://www.prnewswire.com/news-releases/lillys-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-302714000.html
2. Wollenberg A, Werfel T, Ring J, Ott H, Gieler U, Weidinger S. Atopic dermatitis in children and adults—diagnosis and treatment. Dtsch Arztebl Int. 2023;120(13):224-234. doi:10.3238/arztebl.m2023.0011