Phase 3 Trial Supports Lebrikizumab in Pediatric Atopic Dermatitis

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

The IL-13–targeting monoclonal antibody, which is currently approved for the treatment of moderate to severe atopic dermatitis in adults and adolescents, met both co-primary endpoints at week 16. Based on these findings, Lilly indicated it intends to submit the data to US and international regulators seeking a label expansion for use in younger pediatric populations.

“Despite the high prevalence of moderate-to-severe atopic dermatitis in infants and young children, therapeutic options remain limited,” said Amy Paller, MD, chair of the department of dermatology at Northwestern University and an investigator in the study. “The topline results from ADorable-1 suggest that selective IL-13 inhibition with lebrikizumab may offer robust skin clearance and meaningful pruritus reduction in this younger patient population.”

Phase 3 ADorable-1 Trial Design and Outcomes

ADorable-1 (NCT05559359) was a randomized, double-blind, placebo-controlled phase 3 trial that enrolled 363 pediatric patients with moderate to severe atopic dermatitis.

Participants received placebo or weight-based dosing of lebrikizumab. Background topical corticosteroids were required beginning two weeks prior to randomization and continued throughout the 16-week treatment period, with tapering permitted after adequate disease control.

The trial evaluated two co-primary endpoints at week 16:

• Eczema Area and Severity Index improvement of at least 75% (EASI-75) from baseline
• Investigator’s Global Assessment (IGA) score of 0 or 1, with a reduction of at least two points from baseline

Both endpoints were met in the lebrikizumab arm.

• EASI-75: 63% with lebrikizumab vs 22% with placebo
• IGA 0/1: 44% vs 15%, respectively

Key secondary endpoints also favored lebrikizumab. Near-complete clearance (EASI-90) was achieved by 39% of treated patients compared with 11% in the placebo group.

Among patients aged 6 years or older with baseline Pruritus Numeric Rating Scale (NRS) scores ≥4, 35% of those receiving lebrikizumab achieved a clinically meaningful reduction in itch (≥4-point improvement), compared with 6% in the placebo group.

Safety Profile

The safety profile in ADorable-1 was consistent with previously reported findings from adult and adolescent studies, with no new safety signals were identified.

The most common adverse events were upper respiratory tract infections and nasopharyngitis, each occurring in at least 5% of participants, with no notable imbalance between treatment arms. Injection-site reactions occurred at similar rates in both groups, and no injection-site pain was reported.

Clinical Context in Pediatric Atopic Dermatitis

Atopic dermatitis affects approximately 20% to 25% of children, making it one of the most common chronic inflammatory skin diseases in pediatrics. In the United States, an estimated 9.6 million children are affected, with roughly one-third experiencing moderate to severe disease.

Although several systemic biologics are available for adolescents and adults, approved targeted therapies for younger pediatric populations remain limited in comparison, leaving clinicians with relatively few options for infants and young children with persistent or severe disease.

Lebrikizumab selectively inhibits interleukin-13 (IL-13), a key cytokine in type 2 inflammation contributing to epidermal barrier dysfunction, pruritus, lichenification, and susceptibility to cutaneous infection in atopic dermatitis.

According to the company, the antibody’s high binding affinity and slow dissociation kinetics differentiate its pharmacologic profile from agents that target the shared IL-4/IL-13 receptor pathway, such as dupilumab. However, head-to-head comparative data in pediatric populations are not currently available.

References:

1. Eli Lilly and Company. 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 | Eli Lilly and Company. Eli Lilly and Company. Published 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