Phase 3 LumiNE Trial to Assess Lebrikizumab in Nummular Eczema, With Kilian Eyerich, MD, PhD

Almirall has announced plans to launch a phase 3 clinical trial evaluating Lebrikizumab in patients with nummular eczema, expanding ongoing lifecycle development efforts for the biologic beyond its current indication in moderate-to-severe atopic dermatitis.1 The company has said the study reflects its broader focus on advancing dermatology research through targeted therapies and more comprehensive outcome measures that incorporate patient well-being alongside clinical efficacy.

The trial is expected to begin during the first half of 2026. Nummular eczema is a chronic inflammatory skin disorder characterized by recurrent flares that can negatively affect quality of life through severe pruritus, sleep disturbances, and psychosocial burden. The condition may occur independently or alongside atopic dermatitis and is often difficult to diagnose.2 Although distinct from atopic dermatitis and requiring its own approach, researchers believe the diseases may share overlapping inflammatory pathways involving interleukin (IL)-13.

Lebrikizumab, a monoclonal antibody designed to selectively target IL-13, is being investigated in the phase 3 LumiNE trial, a randomized, double-blind, placebo-controlled multicenter study.1 Investigators plan to enroll roughly 270 adults across approximately 60 European sites, with the possibility of expanding enrollment further. Participants will receive treatment for up to 48 weeks, with the study assessing efficacy, safety, and tolerability in individuals whose disease is inadequately controlled with topical corticosteroids or for whom such therapy is not appropriate. The primary endpoint will evaluate improvements in Investigator’s Global Assessment (IGA) scores for nummular eczema, while secondary measures include changes in itch severity and dermatology-related quality of life.

Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany, and guest professor at the Karolinska Institute in Stockholm, Sweden, spoke with HCPLive about this new trial and its potential:

HCPLive: Given the limited treatment landscape for nummular eczema, what unmet needs in clinical practice make this phase 3 study particularly important for dermatologists?

Eyerich: Well, what makes it so important is that it is a prototype disease of many that are neglected in the area of inflammatory skin diseases. I think every dermatologist dreams of reclassifying eczematous diseases. As an example, you are likely very aware that there is not only atopic dermatitis, but there's also prurigo nodularis as a distinct diagnosis. Nummular eczema is one of the most frequent neglected diseases, which shares similarities with atopic dermatitis and prurigo nodularis, but still they're distinct diseases, both clinically and in terms of the pathogenesis. It is one of many diseases, which is quite frequent but understudied, and where we did not or do not have any approved therapeutic options.

HCPLive: That's interesting. The similarity to atopic dermatitis and prurigo nodularis seems unique, because we know the latter disease appears to be substantially impactful on patients' lives compared to eczema, for example.

Eyerich: Yes, and no. The driving symptom for the majority, if not all, of eczematous diseases is pruritus. In prurigo, typically, pruritus is, as you say, most bothersome, but there are also patients with atopic dermatitis and nummular eczema that have pruritus at a comparable intensity, as in prurigo. I wouldn't necessarily generalize it, although I agree with you. If you see it at a disease level, probably prurigo is the most bothersome in terms of the itch.

HCPLive: Additionally, although nummular eczema is distinct from atopic dermatitis, researchers have pointed to IL-13 as a shared inflammatory driver. From a mechanistic standpoint, what makes lebrikizumab a compelling candidate to study in this population?

Eyerich: I would like to start a little broader than that. Because where our disease ontology comes from in dermatology is still from the eye, the pure phenotype, right? It's around 200 years old, or even older. Seeing from that perspective, nummular eczema is a distinct entity, because it comes from a very clear clinical phenotype. But the criteria to diagnose it are not hard and not objective, typically. It's a matter of hallmarks that the dermatologist brings together in order to make this diagnosis. It's just the same as with atopic dermatitis and just the same as with prurigo nodularis.

One important aspect of nummular eczema is that the heterogeneity is so high that there are phenotypes where even the best clinicians could not distinguish it from atopic dermatitis, which makes it so hard to say it's its own disease. Probably quite a few experts in dermatology wouldn't necessarily agree on that. Now, coming from the molecular point of view, it makes total sense for me to define the eczema as its own entity, because, as you say, IL-13 is the backbone immune response in all kinds of eczematous diseases. That, by the way, also includes prurigo, for example. But in the case of nummular eczema, it's not a purely mediated IL-13 disease. There is also an aspect of, for example, neutrophil granulocytes, which is an immune response that is not at all related to type 2 immunity or interleukin-13.

So there are similarities, and there is the shared backbone of IL-13, but nevertheless, there are additional aspects in the pathogenesis of nummular eczema that make it its own entity. Why is that so interesting to dermatologists? Because in these overlapping phenotypes, and we have a lot of these overlapping phenotypes, it was not quite clear whether we would be able to treat them with the specific therapy. Because if now we take IL-13 and neutralize it in nummular eczema, we would still have the component of the neutrophil granulocytes in there, so many dermatologists actually say that these overlapping entities should be treated with older, less specific therapies, such as topical corticosteroids, cyclosporine, and methotrexate.

But from a pathogenic point of view, what seems very interesting is that IL-13 is the dominant driver of nummular eczema. If you treat nummular eczema with a specific biologic against interleukin-13, you improve not only the type 2 immunity, but also the IL-13 and other aspects of inflammation. That is super important because it shows us, as dermatologists, that if we identify the dominant immune source and the driving immunity, we are actually able to treat these patients with nummular eczema just as well as patients with atopic dermatitis.

The quotes contained in this video summary were edited for the purposes of clarity.

Disclosures: Eyerich has previously reported personal fees from Janssen, AbbVie, Almirall, Boehringer Ingelheim, LEO Pharma, Lilly, Novartis, and Sanofi.

References

1. Almirall announces “LumiNE”, a phase III clinical study assessing the efficacy of Lebrikizumab for the treatment of nummular eczema. Almirall, S.A. January 15, 2026. Accessed May 21, 2026. https://www.almirall.com/news-media/newsroom/almirall-announces-lumine-phase-iii-clinical-study-assessing-efficacy.

2. Böhner A, Jargosch M, Eyerich K, et al. The neglected twin: Nummular eczema is a variant of atopic dermatitis with codominant TH2/TH17 immune response. J Allergy Clin Immunol. 2023 Aug;152(2):408-419. doi: 10.1016/j.jaci.2023.04.009. Epub 2023 Apr 27. PMID: 37119871.