お知らせ • Mar 16
Almirall Announces Positive Top-Line Results from Phase 3 Adorable-1 Trial
Almirall, S.A. announced positive, top-line results from the pivotal Phase 3 ADorable-1 trial evaluating efficacy and safety of lebrikizumab for children and adolescents with moderate-to-severe atopic dermatitis aged 6 months to <18 years. In ADorable-1, 363 inadequately controlled patients with moderate-to severe AD aged 6 months to <18 years were randomized to receive a weight-based dose of lebrikizumab or placebo every two weeks or every four weeks. Topical corticosteroids were required two weeks before randomization and throughout the 16-week study but could be decreased or stopped once patients achieved IGA 2 or less. The co-primary endpoints in ADorable-1 were EASI-75 and IGA 0,1 at Week 16. Key secondary endpoints included an even greater clinical improvement in disease severity (EASI-90), itch relief (Pruritus NRS=4-point improvement) and quality of life (CDLQI =6-Point Improvement). Reduced disease severity: 63% of paediatric patients treated with lebrikizumab achieved a significant improvement in disease severity (EASI-75), compared with 22% of patients receiving placebo. Near-complete skin clearance: 44% of children and adolescents treated with lebrikizumab reached clear or almost clear skin (IGA 0,1) by week 16, compared to 15% of those treated with placebo. 39% of patients receiving lebrikizumab achieved an even greater clinical improvement in disease severity (EASI-90), compared to 11% of those receiving placebo. Significant symptom relief: lebrikizumab showed significant itch relief in 35% of patients aged 6 years and older with score =4 at baseline (Pruritus NRS=4 point improvement), in contrast with 6% of patients treated with placebo. Improved quality of life: 62% of paediatric patients treated with lebrikizumab, compared with 36% of those treated with placebo, saw an improvement in quality of life (CDLQI =6-Point Improvement), demonstrating benefits across a broad range of key health-related indicators, including symptoms, emotional impact, leisure activities, school or holidays, personal relationships, sleep, and treatment burden. The results from Phase 3 ADorable-1 trial are consistent with the established safety profile of lebrikizumab, approved in Europe for adult and adolescent patients older than 12 years old, with no new safety signals observed. The most common adverse events in the study reported by 5% of participants were upper respiratory tract infections and nasopharyngitis, with no numerical imbalance between treatment groups. Injection site reactions were reported similarly in both the lebrikizumab and placebo arms. ADorable-1 results provide important evidence to advance paediatric development program for lebrikizumab in moderate to- severe- atopic dermatitis. The ADorable clinical program is ongoing. Additional results from ADorable-1 and ADorable-2, a 52-week extension study of patients enrolled in ADorable-1, will be disclosed later this year. Almirall continues to show its commitment to science and its efforts to address patient needs through a new Phase 3 trial of lebrikizumab in patients with nummular eczema and multiple ongoing studies that will further extend the evidence base for its biologics treatments. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe, while Eli Lilly and Company retains rights for development and commercialization in the U.S. and the rest of the world outside Europe. ADorable-1 is a multicenter, randomized, double blind, placebo-controlled phase 3 trial in 363 children and adolescents with moderate-to-severe atopic dermatitis that evaluated lebrikizumab vs placebo on top of standardized low-to-medium potency topical corticosteroids (TCS). Coprimary efficacy endpoints at Week 16 are IGA 0/1 with =2point improvement and EASI75, with key secondary endpoints including EASI90, pruritus NRS, cDLQI, and others. ADorable-1 is part of the ADorable clinical program designed to assess lebrikizumab efficacy and safety for paediatric patients in two phase 3 clinical trials: ADorable-1 and ADorable-2. Lebrikizumab (LEB) is a monoclonal antibody that selectively targets the cytokine IL-13 with high affinity, blocking its downstream signaling, while avoiding broader immunosuppression and preserving IL-13 physiological clearance. Lebrikizumab is approved in Europe, under the brand name Ebglyss®, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.