UCB announces successful first-in-patient trial for galvokimig in moderate-to-severe atopic dermatitis at EADV

Brussels (Belgium), September 18, 2025 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced new 12-week efficacy and 18-week safety data from the Phase 1/2a first-in-patient trial for galvokimig, a novel multi-specific antibody-based therapeutic currently under clinical investigation for adults living with moderate-to severe atopic dermatitis (AD). Galvokimig demonstrated clinically meaningful improvements in stringent efficacy measures for AD,¹ a common, chronic, inflammatory skin disease affecting 2–10% of adults worldwide.² 

“The study showed that many patients achieved the stringent EASI75 and EASI90 outcomes at Week 12 with galvokimig in this early-stage trial. The data indicate the potential of galvokimig to deliver clinically meaningful improvements in larger-scale clinical trials for patients with atopic dermatitis,” said Professor Jonathan Silverberg,≠ MD, PhD, MPH, Professor of Dermatology at the George Washington University School of Medicine & Health Sciences in Washington, DC. “These encouraging results provide support for targeting both Th2 and Th17 inflammatory pathways in patients with this debilitating inflammatory disease and I look forward to results from the Phase 2b clinical program.”

In the Phase 2a trial, patients (n=47) received galvokimig (n=33) or placebo (n=14).¹ At Week 12, a median of 64.9% of patients achieved EASI75 with galvokimig versus 12.3% with placebo.^1* Also at Week 12, a median of 46.6% of patients achieved EASI90 with galvokimig versus 3.5% with placebo.^1* 

After 18 weeks, the most common treatment-emergent adverse events (TEAEs) with galvokimig were rhinitis, nasopharyngitis, headache, dizziness and oropharyngeal pain.¹ 

“Atopic dermatitis is the most common, chronic, inflammatory skin disease, affecting millions of people across the world, that can have far-reaching consequences for the everyday lives of patients and their families,” said Donatello Crocetta, Head of Medical and Chief Medical Officer, UCB. “Many patients experience sub-optimal treatment responses, in part due to the complex variety of inflammatory mechanisms involved in this disease, underscoring the need for new treatment options for those living with this distressing condition.”

Galvokimig is currently under clinical investigation and is not approved by any regulatory authority worldwide.

UCB’s abstract on galvokimig will be presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France, 17–20 September. The abstract complements the 19 other presentations from UCB in bimekizumab data across hidradenitis suppurativa, psoriasis, psoriatic arthritis and axial spondyloarthritis – emphasizing UCB’s strong commitment to addressing unmet health needs for people living with immune-mediated inflammatory diseases.

^≠Co-author.

^*NRI: non-responder imputation. All visits following discontinuation due to adverse events or lack of efficacy were treated as non-response.

Notes to Editors:

• EASI75/EASI90: A 75% and 90% or more improvement from baseline, respectively, in the Eczema Area and Severity Index (EASI).³ The EASI assessment integrates body surface area of involvement and the intensity of lesional skin into one composite score.⁴

About atopic dermatitis 

Atopic dermatitis (AD) is a heterogeneous disease affecting both children and adults, and is driven by a combination of chronic inflammation, epidermal dysfunction and a dysregulated skin barrier.^5,6,7  AD is characterized by recurrent skin lesions presenting as erythematous patches with exudation, blistering and crusting at early stages, and lichenification at later stages, as well as intense itch.⁵ AD affects 2–10% of adults and 15–30% of children worldwide.² The prevalence of AD has grown by 0.98% per decade in adolescents and by 1.21% per decade in children globally.⁸  AD significantly lowers the quality of life for patients and their families, being associated with sleep disturbance,
anxiety, hyperactivity and depression.⁹ 

About the first-in-human trial

The study was a two-part, randomized, first-in-human, proof-of-concept, double-blind Phase 1/2a study of galvokimig monotherapy.¹ In part A of the study, healthy study participants received either placebo or single ascending doses of galvokimig administered by intravenous infusion or subcutaneous injection. In part B, patients with moderate-to-severe atopic dermatitis (AD) were randomized 2:1 to receive either galvokimig or placebo by intravenous infusion.¹⁰ Patients with AD were enrolled in part B of the study and randomized 2:1 to receive intravenous galvokimig or placebo.¹ The primary endpoints  in part B were ≥75% improvement from baseline in Eczema Area and Severity Index (EASI75) response rate at Week 12 and incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs from baseline to Week 18.1

About galvokimig

Galvokimig is a multi-specific antibody-based therapeutic that is designed to inhibit IL-13, IL-17A and IL-17F, with an extended half-life through albumin binding.¹ By targeting both Th2 (via IL-13) and Th17 pathways (via IL-17A/F), combined IL-13, IL-17A and IL-17F inhibition with a single agent may improve treatment outcomes in people with atopic dermatitis.¹ The safety and efficacy of galvokimig have not been established and it is not currently approved for use in any indication by any regulatory authority worldwide.

For further information, contact UCB: 

Investor Relations
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com 

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@ucb.com

Brand Communications
Adriaan Snauwaert
T +32.4.977.02.346
email adriaan.snauwaert@ucb.com

About UCB 

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB).

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References

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4. Hanifin JM, et al. The Eczema Area and Severity Index—A Practical Guide. Dermatitis. 2022;33(3):187–92.
5. Langan SM, et al. Atopic dermatitis. Lancet. 2020;396(10247):345–60.
6. Bakker D, et al. Biomarkers in atopic dermatitis. J Allergy Clin Immunol. 2023;151(5):1163–68.
7. Criado PR, et al. Update on the pathogenesis of atopic dermatitis. An Bras Dermatol. 2024;99(6):895–915.
8. Langan S, et al. Trends in eczema prevalence in children and adolescents: A Global Asthma Network Phase I Study. Clin Exp Allergy. 2023;53(3):337–52. 
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10. ClinicalTrials.gov. NCT04643457. https://www.clinicaltrials.gov/study/NCT04643457. Last accessed: September 2025.