Eli Lilly and Company has reported positive topline results from the Phase 3 ADorable‑1 trial evaluating EBGLYSS (lebrikizumab‑lbkz) in pediatric patients aged six months to 18 years with moderate‑to‑severe atopic dermatitis. The study met its primary and key secondary endpoints at Week 16, with EBGLYSS improving overall disease severity, skin clearance, and itch compared with placebo.
EBGLYSS is a monoclonal antibody that selectively inhibits interleukin‑13 (IL‑13) signaling, a key cytokine implicated in the type 2 inflammatory pathway that contributes to skin barrier dysfunction, pruritus, skin thickening, and risk of infection in atopic dermatitis. In ADorable‑1, participants were randomized to receive placebo or weight‑based EBGLYSS in combination with topical corticosteroids, which were started two weeks before randomization and continued through the 16‑week treatment period, with tapering allowed once patients reached an Investigator’s Global Assessment (IGA) score of 2 or less. Co‑primary endpoints were the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index (EASI‑75) and IGA 0/1 at Week 16, while key secondary endpoints included EASI‑90 and a Pruritus Numeric Rating Scale improvement of at least four points.
Lilly reported that the safety profile of EBGLYSS in ADorable‑1 was consistent with that seen in adults and adolescents, with no new safety signals identified. The most common adverse events occurring in at least 5% of participants were upper respiratory tract infection and nasopharyngitis, with similar rates between treatment and placebo arms, and injection‑site reactions were reported at comparable frequencies without injection‑site pain. Lilly plans to submit the ADorable‑1 data to U.S. and other global regulators to support a potential label update to extend EBGLYSS use to younger pediatric patients.
The ADorable program includes ADorable‑1 and ADorable‑2, a 52‑week extension study for participants from ADorable‑1, with additional data expected later this year. EBGLYSS is already approved for moderate‑to‑severe atopic dermatitis in adults and adolescents in multiple regions, and Lilly holds exclusive development and commercialization rights outside Europe, where Almirall is responsible for dermatology indications including atopic dermatitis.
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