Galvokimig Achieves High EASI Scores in Pilot Study

A new investigational therapy, galvokimig (UCB), has demonstrated encouraging early results in patients with moderate to severe atopic dermatitis (AD), according to recently released data from a phase 1/2a first-in-patient trial. UCB, a global biopharmaceutical company, announced the 12-week efficacy and 18-week safety findings, which will be presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris, France.¹

Study Design

The first-in-human trial was structured in 2 parts: Part A assessed safety in healthy participants receiving single ascending doses of galvokimig or placebo via intravenous or subcutaneous administration, and part B focused on efficacy and safety in adults with moderate to severe AD. In this stage, 47 patients were randomly assigned 2:1 to receive intravenous galvokimig (n = 33) or placebo (n = 14).

The primary efficacy end point was the proportion of patients achieving at least 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at week 12. Safety end points included the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs through week 18.

Efficacy Outcomes

Results from the trial showed notable improvements among patients receiving galvokimig. At week 12, a median of 64.9% of patients treated with galvokimig achieved EASI-75 compared with 12.3% in the placebo group. Furthermore, 46.6% of galvokimig-treated patients achieved the more stringent EASI-90 outcome vs 3.5% of patients on placebo.

“The study showed that many patients achieved the stringent EASI-75 and EASI-90 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 Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at the George Washington University School of Medicine and 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.”

Safety Findings

Over the 18-week observation period, the most commonly reported TEAEs in the galvokimig group included rhinitis, nasopharyngitis, headache, dizziness, and oropharyngeal pain. No new or unexpected safety signals were reported in this early-phase study. However, the limited sample size and short duration mean that larger trials are needed to better establish the therapy’s safety profile.

Mechanism of Action

Galvokimig is a multispecific antibody-based therapeutic designed to simultaneously inhibit IL-13, IL-17A, and IL-17F, with an extended half-life achieved through albumin binding. By targeting both Th2-driven (via IL-13) and Th17-driven (via IL-17A and IL-17F) inflammatory pathways, galvokimig aims to address the heterogeneity of AD pathophysiology.²

Next Steps

Although the results are promising, galvokimig remains an investigational therapy and has not been approved by regulatory authorities. Larger, longer-term studies—including the ongoing phase 2b program—will be required to confirm the clinical benefits and safety profile observed in this early trial.

According to Donatello Crocetta, MD, MBA, UCB’s global head of medical communities and chief medical officer, the results highlight the ongoing need for new treatment approaches. “Many patients experience suboptimal 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.”

Conclusion

The phase 1/2a results suggest that galvokimig has the potential to provide meaningful clinical improvements for patients with moderate to severe AD by targeting multiple immune pathways. Although further investigation is required, the findings contribute to a growing body of research exploring multitargeted therapies for chronic inflammatory diseases.

References

1. UCB announces successful first-in-patient trial for galvokimig in moderate-to-severe atopic dermatitis at EADV. News release. UCB. September 18, 2025. Accessed September 18, 2025. https://www.ucb.com/newsroom/press-releases/article/ucb-announces-successful-first-in-patient-trial-for-galvokimig-in-moderate-to-severe-atopic-dermatitis-at-eadv
2. Yue C, Zhou H, Wang X, et al. Atopic dermatitis: pathogenesis and therapeutic intervention. MedComm (2020). 2024;5(12):e70029. doi:10.1002/mco2.70029