Eli Lilly reports positive Phase 3 ADorable-1 results for EBGLYSS (lebrikizumab-lbkz) in pediatric atopic dermatitis, showing significant skin clearance and itch relief at Week 16.
Written By: Nikita Jha, BPharm and Anand Sathappan BPharm
Reviewed By: Pharmacally Editorial Team
Eli Lilly and Company announced positive topline results from the Phase 3 ADorable-1 trial evaluating EBGLYSS (lebrikizumab-lbkz) in pediatric patients with moderate-to-severe atopic dermatitis. The study met its primary and key secondary endpoints at Week 16, demonstrating significant improvements in disease severity, skin clearance, and itch relief compared with placebo. Lilly plans to submit the data to U.S. and global regulators to support a potential label expansion for younger pediatric populations.
EBGLYSS is a monoclonal antibody that selectively inhibits interleukin-13 (IL-13) signaling. IL-13 is a key cytokine driving the type-2 inflammatory pathway in atopic dermatitis, contributing to skin barrier dysfunction, chronic itch, skin thickening, and infection. By blocking IL-13 with high binding affinity and a slow dissociation rate, EBGLYSS targets the underlying inflammatory mechanism of the disease.
ADorable-1 (NCT05559359) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating EBGLYSS in infants and children as young as six months with moderate-to-severe atopic dermatitis. The trial enrolled 363 patients, who were randomized to receive placebo or weight-based EBGLYSS dosing.
All participants used topical corticosteroids starting two weeks before randomization and throughout the 16-week study, though treatment could be reduced or discontinued once patients achieved Investigator’s Global Assessment (IGA) scores of 2 or less.
At Week 16, 63% of patients treated with EBGLYSS achieved EASI-75, compared with 22% in the placebo group. IGA 0/1 with a ≥2-point reduction from baseline was observed in 44% of EBGLYSS-treated patients versus 15% with placebo. Deeper clinical responses were also reported, with EASI-90 achieved in 39% of patients receiving EBGLYSS compared with 11% in the placebo arm. Among children aged six years and older with significant baseline itch, 35% of EBGLYSS-treated patients achieved at least a 4-point improvement in Pruritus NRS, compared with 6% in the placebo group.
Adrienne Brown, executive vice president and president of Lilly Immunology, said children with moderate-to-severe atopic dermatitis often experience persistent flares and intense itching that disrupt daily life. She noted that EBGLYSS has already demonstrated durable benefits in adults and adolescents and that these results show the therapy can also provide meaningful disease control in younger patients.
The safety profile of EBGLYSS in the study was consistent with previous trials in adults and adolescents, with no new safety signals identified. The most common adverse events reported in at least 5% of participants were upper respiratory tract infections and nasopharyngitis, with similar rates between treatment groups. Injection-site reactions occurred at comparable frequencies in both EBGLYSS and placebo arms, and no injection-site pain was reported.
Amy Paller, MD, chair of dermatology at Northwestern University and an investigator in the ADorable program, highlighted that infants and young children with moderate-to-severe atopic dermatitis currently have limited treatment options. She said the results suggest EBGLYSS could offer substantial skin clearance and itch relief by targeting the inflammatory drivers of the disease.
The ADorable clinical program remains ongoing, and Lilly expects to report additional data from both ADorable-1 and ADorable-2, a 52-week extension study, later this year.
EBGLYSS is currently approved in the United States, Japan, and Canada (2024) and in the European Union (2023) for patients aged 12 years and older with moderate-to-severe atopic dermatitis that is not adequately controlled with topical therapies. Lilly holds global development and commercialization rights outside Europe, where Almirall leads commercialization for dermatology indications.
For full prescribing details, including indication, dosing, warnings, precautions, and safety information, see the U.S. Prescribing Information for EBGLYSS: EBGLYSS U.S. Prescribing Information (USPI)
Reference
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, 16 March 2026, 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
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis (ADorable-1), ClinicalTrials.gov ID NCT05559359, https://clinicaltrials.gov/study/NCT05559359
Lebrikizumab delivered significant skin clearance and improved disease severity in children with moderate-to-severe atopic dermatitis, 16 March 2026, https://www.almirall.com/newsroom/news/lebrikizumab*-proporciona-un-aclaramiento-de-la-piel-significativo-y-mejora-la-gravedad-de-la-enfermedad-en-ni%C3%B1os-con-dermatitis-at%C3%B3pica-moderada-a-grave-1
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. He has completed the Medical Writing Skills for Beginners program offered by the International Medical Writers Association (IMWA). His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.