BARCELONA, Spain, March 16 — Almirall, S.A. (ALM), a global biopharmaceutical company focused on medical dermatology, today 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. Lebrikizumab met both co-primary and key secondary endpoints, delivering near-complete skin clearance, reduced disease severity, itch relief and improved quality of life at Week 16.
Skin conditions can have a significant impact on people’s lives, both physically and emotionally3. Atopic dermatitis is more prevalent in childhood than adulthood and typically begins early in life4, with most cases appearing by the first year of life (60%) or before 5 years of age (85%)5. The emotional impact of atopic dermatitis can disrupt crucial formative years, with disease burden increasing alongside severity and often leading to sleep disruption, school absenteeism, and difficulties in socializing6.
“At Almirall, we are committed to advancing skin science through a holistic approach to disease management, recognizing the profound effect skin conditions have on people’s lives. We are excited about the positive, top-line results from the Phase 3 ADorable-1 trial and the meaningful impact they could have on children and adolescents and their life trajectories,” said Dr Karl Ziegelbauer, Chief Scientific Officer at Almirall.
“Children with atopic dermatitis still face considerable unmet needs, with persistent symptoms, limited treatment options, and a disease burden that grows with severity. There is a need for advanced treatment solutions, considering the specific challenges of younger patients and their families.”, said Prof Weidinger, Department of Dermatology, Allergology and Venerology at University Hospital Schleswig-Holstein, Kiel, Germany.
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).
Key efficacy results in ADorable-1 at Week 16
- 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 our 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 continues to strengthen its leadership in medical dermatology through sustained investment in science, cutting edge R&D capabilities, and a pipeline designed to tackle some of the most significant unmet needs in skin health. Leveraging strong scientific expertise, global collaborations and partnerships with dermatologists, the company is advancing a diverse portfolio that uses novel modalities to address debilitating conditions such as hidradenitis suppurativa, alopecia areata, and atopic dermatitis. Its early-stage clinical program currently includes three ongoing PoC/Phase II studies, with three additional PoC trials planned for 2026, and the progression of a bispecific antibody targeting IL13 and OX40L into Phase I.
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.
