Almirall has announced plans to initiate a phase 3 clinical study evaluating lebrikizumab for the treatment of nummular eczema, a chronic inflammatory skin condition with limited approved systemic treatment options.

The study, known as LumiNE, is expected to begin in the first half of 2026 and will assess the efficacy, safety and tolerability of lebrikizumab in at least 270 adult patients with nummular eczema across Europe. Treatment will be administered for up to 48 weeks.

Nummular eczema, also referred to as discoid eczema, is a distinct condition from atopic dermatitis, although the two diseases share overlapping inflammatory pathways. Research suggests the cytokine IL-13 plays a central role in disease pathogenesis in both conditions, making IL-13 inhibition a potential therapeutic strategy for patients with nummular eczema who are inadequately controlled with topical therapies.

Lebrikizumab is a monoclonal antibody that selectively targets IL-13 and is already approved in Europe for the treatment of moderate-to-severe atopic dermatitis. Almirall said the LumiNE study forms part of its lifecycle management strategy to extend the clinical benefit of existing dermatology treatments to additional patient populations with high unmet medical need.

The LumiNE trial is designed as a randomized, double-blind, placebo-controlled, multicentre study with a double-blind extension. Approximately 270 participants will be enrolled across around 60 centres in Europe, with the potential to expand recruitment. The primary endpoint is improvement in the Investigator’s Global Assessment of nummular eczema, with key secondary endpoints including pruritus numerical rating scale improvement and absolute change in Dermatology Life Quality Index scores.

Karl Ziegelbauer, chief scientific officer at Almirall, said: “We are excited to start this phase 3 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.”

Nummular eczema is characterised by coin-shaped, inflamed, itchy skin lesions and is frequently relapsing. The condition can occur in individuals with or without atopic dermatitis and is often difficult to manage with standard topical corticosteroids. Persistent itch, sleep disruption and visible skin lesions can significantly affect quality of life.

According to published data, the estimated prevalence of nummular eczema ranges from 0.1 percent to 9 percent, with higher rates reported in older adults and certain ethnic populations. The condition is also commonly misdiagnosed due to similarities with other inflammatory dermatoses, contributing to delays in appropriate treatment.

LumiNE coordinating investigator Kilian Eyerich, medical director of the department of dermatology and venereology at the medical center of the University of Freiburg, said: “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 3 study as soon as possible and to assessing the potential for lebrikizumab to extend its benefits to addressing nummular eczema.”

Almirall said the study reflects its continued focus on medical dermatology and on advancing targeted therapies for chronic inflammatory skin diseases where treatment options remain limited.