Pharmaceutical Market Europe • February 2026 • 10

DERMATOLOGY NEWS

LEO Pharma’s Anzupgo cream progresses to phase 3 trial for lichen sclerosus

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LEO Pharma has announced a phase 3 trial of delgocitinib cream to treat adults with mild to severe lichen sclerosus (LS).

The phase 2b REZOLVE-AA trial includes 92 patients, randomised to receive either one of two rezpegaldesleukin doses or a placebo.

The DELTA CARE 1 trial will initially recruit 300 women, followed by a further 352 men and women, from 80-90 global sites in the US, Canada, the UK, Germany, Frace, Italy, Spain and Poland.

LS is a chronic, inflammatory skin condition that occurs more commonly in women than men. For women, it often appears in childhood before puberty and again around or after menopause, while for men it often appears in young adulthood or after the age of 60.

Symptoms include white patches of skin, itching, soreness and scarring, which can lead to sexual and urinary dysfunction in both women and men – all of which can affect patients’ quality of life, impacting daily activities and emotional well-being.

Anzupgo is currently approved in the US, the EU and several other markets for adult patients with moderate to severe chronic hand eczema. LEO Pharma is now investigating LS and exploring additional disease areas, where delgocitinib could address significant unmet medical needs.


Sanofi’s amlitelimab shows positive results in atopic dermatitis

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Sanofi has announced that its drug, amlitelimab, has shown positive results in the treatment of patients 12 years and older with atopic dermatitis (AD).

Positive results from the COAST 1 study were announced in September 2025. Sanofi has now released study data from the global phase 2 SHORE and COAST 2 studies of amlitelimab, a non-T cell depleting monoclonal antibody designed to target OX40-ligand (OX40L).

Both the SHORE and COAST 2 studies evaluated amlitelimab as a treatment for patients over the age of 12 with moderate to severe AD. The treatment was given either every four weeks or every 12 weeks. The SHORE study found that both doses, together with medium-potency background topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), met primary and key secondary endpoints compared with placebo plus TCS with or without TCI.

The COAST 2 study found that both doses of amlitelimab as a monotherapy met the study’s primary endpoint at week 24.

The treatment presented a favourable safety and tolerability profile in both studies. Rates of treatment-emergent adverse events were consistent between treatment and placebo arms.


DEBRA Research and Netherlands university launch clinical trial site for EB

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Dystrophic Epidermolysis Bullosa Research Association (DEBRA) Research and the University Medical Center Groningen (UMCG) in the Netherlands have launched a dedicated clinical trial site at UMCG to study epidermolysis bullosa (EB).

EB refers to a group of rare genetic skin disorders. The main symptom of these disorders is extremely fragile skin that causes frequent blisters and wounds, leading to debilitating pain.

UMCG is an established leader in the diagnosis and care of EB through its Center of Expertise for Blistering Diseases. The new collaboration and research site will drive EB research and increase the capacity for clinical research into EB.
The advantages of specialised trial sites include improved efficiency, greater recruitment and a patient-centric approach generated by centralising expertise within a dedicated location.

The site will host both company-sponsored and investigator-initiated trials. International EB initiatives will also be involved with research at the new site.

An increase in specialised clinical trial capacity, combined with scientific contributions to research on EB, will mark a major development in approaches to this rare and debilitating disorder.

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