- Nummular eczema is a debilitating skin condition that is distinct from atopic dermatitis but involves similar disease mechanisms including IL-13 and therefore makes targeting IL-13 with lebrikizumab a potentially promising therapeutic option.
- LumiNE is part of Almirall’s ongoing lifecycle management activities to enable more patients to benefit from advanced treatments – such as Lebrikizumab – targeting patients with dermatological conditions and high unmet medical needs.
- The phase III study will be initiated within the first half of 2026 and will evaluate the efficacy, safety, and tolerability of lebrikizumab in at least 270 patients with nummular eczema in Europe for up to 48 weeks of treatment.
BARCELONA, Spain–(BUSINESS WIRE)–Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology, announces the planned start of a phase III study assessing the efficacy and safety of Lebrikizumab (Ebglyss®, currently approved for the treatment of moderate-to-severe atopic dermatitis) in patients with nummular eczema. This study will be initiated in the first half of 2026 and is aligned with Almirall’s ambition of leadership in medical dermatology and is part of the ongoing lifecycle management activities Almirall is conducting for its products to enable more patients to benefit from advanced treatments targeting dermatological conditions with high unmet medical need.
Nummular eczema is distinct condition from atopic dermatitis, requiring a specific treatment regime, but is thought to involve a similar disease mechanism with the cytokine IL-13 playing a key role. This makes targeting IL-13 by lebrikizumab – a monoclonal antibody with high affinity to IL-13 – a potentially promising therapeutic option for patients suffering from nummular eczema.
“We are excited to start this phase III study with lebrikizumab in patients suffering from nummular eczema as it has the potential to make a meaningful difference in the treatment of this debilitating disease. The proven efficacy of lebrikizumab in atopic dermatitis, its high affinity to the cytokine IL-13, and the scientific evidence pointing to a central role of IL-13 also in nummular eczema could enable us to expand the benefits of lebrikizumab to these patients, in line with Almirall’s purpose to transform people’s lives” stated Karl Ziegelbauer, Chief Scientific Officer at Almirall.
“This is an important clinical study as it is aimed at addressing the unmet needs of patients living with nummular eczema, and the latest scientific insights that show a potential role of IL-13 in the development of this debilitating chronic skin disease. We are looking forward to initiating this phase III study as soon as possible and to assessing the potential for lebrikizumab to extend its benefits to addressing nummular eczema” commented LumiNE coordinating investigator Prof. Dr. Kilian Eyerich, Medical Director of the Department of Dermatology and Venereology at the Medical Center University of Freiburg, Germany.
About LumiNE
LumiNE (M-27501-30) is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multicenter clinical trial with a double-blind extension evaluating efficacy, safety, and tolerability of lebrikizumab for up to 48 weeks of treatment in adult participants with nummular eczema who are not adequately controlled with topical corticosteroids or when this treatment is not medically advisable. The study is planned to be initiated within the first half of 2026 and will initially randomize approximately 270 participants at around 60 centres across Europe, with a potential extension to additional patients. The primary endpoint is the improvement of IGA-NE (Investigator’s Global Assessment of nummular eczema) and the key secondary endpoints are pruritus NRS (Numerical Rating Scale) improvement from baseline and absolute change in DLQI (Dermatology Life Quality Index).
About nummular eczema
Nummular eczema (NE) is a chronic skin disorder characterized by red, scaly, itchy, coin-shaped patches and is often difficult to manage with standard topical therapies. NE, also referred to as discoid eczema, may present in individuals with or without atopic dermatitis and is a frequently relapsing inflammatory skin condition which significantly impairs the patients’ quality of life due to persistent itch, sleep disruption, and social stigma. NE has an estimated prevalence range from 0.1% to 9%, with higher prevalence in older adults and specific ethnic populations. It is frequently misdiagnosed due to its resemblance to other inflammatory dermatoses.
While NE shares some features such as barrier dysfunction and type 2 immune activation with atopic dermatitis, it is a distinct clinical condition that may present in individuals with or without atopic dermatitis. A growing body of evidence suggests NE requires specific tailored diagnostic and therapeutic approaches. Recent scientific data show that the cytokine IL-13 is a central mediator in NE and plays an important role in the onset and relapse of the disease, specifically contributing to triggering inflammation, pruritus, eosinophilic infiltration, and barrier dysfunction in NE.
About Lebrikizumab
Lebrikizumab is a high-affinity monoclonal antibody that selectively binds the cytokine IL-13 which is a factor in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. Lebrikizumab (Egblyss®), currently approved for the treatment of moderate-to-severe atopic dermatitis) prevents the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thus inhibiting the biological effects of IL-13 and its role in the disease pathogenesis of Atopic dermatitis. Lebrikizumab represents a step forward for patients with moderate-to-severe AD not controlled with topical therapy due to its selective mechanism of action, proven efficacy, favorable safety profile, and a 4-weekly maintenance dosing. Lebrikizumab has demonstrated clinical efficacy in both, monotherapy and in combination with topical corticosteroids with 4-weekly maintenance dosing across a variety of clinical studies and in real-world evidence settings.
Ebglyss was approved in Europe in October 2023 and in the US in August 2024. Almirall has exclusive rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe. Almirall´s partner Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe.
About Almirall
Almirall is a global pharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.
For more information, please visit almirall.com
Legal notice:
This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are “forward-looking statements.” These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law.
Contacts
Corporate Communications:
[email protected]
Phone: (+34) 659 614 173
Investor Relations
[email protected]
Phone: (+34) 93 291 30 87
