Lilly's EBGLYSS Delivers Positive Phase 3 Outcomes in Pediatric Atopic Dermatitis

First and only selective IL-13 inhibitor to show efficacy in patients aged 6 months to 18 years with moderate-to-severe disease

Mar. 16, 2026 at 11:27am

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Eli Lilly and Company announced positive topline results from the Phase 3 ADorable-1 trial evaluating the safety and efficacy of EBGLYSS (lebrikizumab-lbkz) in pediatric patients with moderate-to-severe atopic dermatitis. EBGLYSS met the primary and key secondary endpoints at Week 16, improving disease severity while delivering skin clearance and relief from persistent itch.

Why it matters

Atopic dermatitis is more common in children than adults, affecting 9.6 million children in the U.S., one-third of whom have moderate-to-severe disease. These positive results offer hope for young patients who have fewer approved treatment options than adults and adolescents.

The details

In the ADorable-1 study, 63% of patients achieved meaningful skin improvement (EASI-75) and 44% achieved clear or almost clear skin (IGA 0,1) at Week 16. Key secondary endpoints showed 39% of patients achieved a high bar of near-complete skin clearance (EASI-90) and 35% achieved significant itch relief (Pruritus NRS ≥ 4-point improvement). The safety profile was consistent with adult and adolescent studies, with no injection site pain reported.

  • The ADorable clinical program is ongoing, with additional results from ADorable-1 and ADorable-2 expected later this year.

The players

Eli Lilly and Company

An American pharmaceutical company that develops and markets medicines, including EBGLYSS, a monoclonal antibody that selectively targets and neutralizes IL-13.

EBGLYSS (lebrikizumab-lbkz)

Lilly's IL-13 inhibitor that has shown positive Phase 3 results in treating moderate-to-severe atopic dermatitis in pediatric patients.

Amy Paller, M.D.

Chair of the department of dermatology at Northwestern University and an ADorable study investigator.

Adrienne Brown

Executive vice president and president of Lilly Immunology.

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What they’re saying

“Children with moderate-to-severe atopic dermatitis often endure relentless skin flares, itch and discomfort that can disrupt play, school and daily life for patients and caregivers. EBGLYSS 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 EBGLYSS also provided disease control in pediatric patients, a critical milestone that, if approved, could bring profound relief to these patients and their families.”

— Adrienne Brown, Executive vice president and president, Lilly Immunology

“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. 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.”

— Amy Paller, M.D., Chair, department of dermatology at Northwestern University and ADorable study investigator

What’s next

The ADorable clinical program is ongoing, with additional results from ADorable-1 and ADorable-2 expected later this year. Lilly plans to submit these data to U.S. and global regulators for a potential label update for EBGLYSS.

The takeaway

These positive Phase 3 results for EBGLYSS in pediatric patients with moderate-to-severe atopic dermatitis represent a significant milestone, as they could bring much-needed relief to young patients and their families who have limited treatment options currently available.