Eli Lilly’s Ebglyss (lebrikizumab-lbkz) has reduced the severity of atopic dermatitis (AD) in children as young as six months, with the drugmaker now eyeing an expansion to its already approved patient population.
In the Phase III ADorable-1 trial (NCT05559359), 63% of patients treated with the interleukin-13 (IL-13) inhibitor achieved meaningful skin improvement (EASI-75) and 44% achieved clear or almost clear skin (IGA 0,1) after 16 weeks, achieving both co-primary endpoints. This is compared to 22% and 15% of placebo-treated patients, respectively, achieving these endpoints.
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Key secondary endpoints were also achieved, with 39% of patients reaching a high bar of near-complete skin clearance (EASI-90) and 35% achieving significant itch relief (Pruritus NRS ≥4-point improvement). The same endpoints were attained in 11% and 6% of patients who received placebo, respectively.
The safety of Ebglyss was consistent with the known profile in adult and adolescent patients, with no new safety signals observed.
Based on the study, Lilly will submit data to the US Food and Drug Administration (FDA) and global regulators for a potential label update to include patients aged over six months. The drug is already approved for AD in adults and children aged 12 years and over.
Dr Amy Paller, chair, department of dermatology at Northwestern University and ADorable study investigator, said: “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 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.”
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By GlobalDataThe drug is being investigated in other AD studies as part of the ADorable clinical programme. Data from Adorable-2 and additional data from Adorable-1 are set to be released later in 2026.
While Lilly has exclusive rights for the development and commercialisation of Ebglyss in the US and the rest of the world outside Europe, its partner Almirall has licensed the rights to develop and commercialise the drug for the treatment of dermatology indications, including AD, in Europe.
AD, which is also known as eczema, is more common in children than adults, affecting 9.6 million children in the US, one-third of whom have moderate-to-severe disease.
Much of the global AD market is dominated by Sanofi and Regeneron’s Dupixent (dupilumab), a monoclonal antibody (mAb) that inhibits IL-4 and IL-13. After its initial approval in 2017 for adults, it has since gained approval for patients aged 12 to 17 years of age in 2019, for children aged six to 11 years in 2020, and for patients aged between six months and five years of age in 2022. It has become the gold standard treatment for AD, bringing in $17.8bn in 2025; however, this figure includes its use in all inflammatory indications for which it is approved.
As the 2031 patent expiry of Dupixent looms, Sanofi has the drug’s successor, amlitelimab, ready for regulators, despite it missing one of the co-primary endpoints in a Phase III trial.
According to a GlobalData report, the AD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) is forecast to grow from $8.5bn in 2023 to $21.5bn in 2033.
GlobalData analysts added that prior to Dupixent’s approval in 2017, the AD market had remained stagnant and the pipeline for drugs in late-stage development was lacking, but recent developments have reignited interest in the treatment of the disease, especially as the estimated drug-treated population may grow to over 28 million people over the next decade.
GlobalData is the parent company of Clinical Trials Arena.
