Barzolvolimab Provides Long-Term Improvements for Spontaneous Urticaria

After 52 weeks of barzolvolimab, participants saw continued treatment efficacy an additional 28 weeks after their last dose

MILWAUKEE, Feb. 11, 2026 /PRNewswire/ -- Barzolvolimab was found to produce prolonged improvements for patients with spontaneous urticaria, according to new research being presented at the 2026 AAAAI Annual Meeting.

"I believe barzolvolimab's unique ability to target the underlying driver of CSU—the mast cell—resulted in unprecedented rapid, profound and durable complete responses in this large Phase 2 study, with up to 51% of patients achieving a complete response, no itch or hives, at 12 weeks which continued to deepen over 52 weeks of treatment to up to 71% of patients," said lead author Martin Metz, MD, Professor, Department of Dermatology and Allergy, Head of Translational Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin. "In this sub analysis of patients who completed 52 weeks of treatment with at least well controlled disease, the majority had a complete response seven months after their last dose and for those who did experience disease return, it was generally mild – these results are especially impressive given most of these patients entered the study with severe disease. This prolonged, off treatment efficacy is suggestive of a disease modifying mechanism and demonstrates the significant potential of barzolvolimab to become a transformative treatment option for patients suffering from CSU."

In this double-blind, placebo-controlled trial, patients with antihistamine refractory CSU were enrolled and treated for up to 52 weeks. Some participants were randomized to treatment with either 150mg of barzolvolimab every four weeks or 300mg of barzolvolimab every eight weeks, and 78 patients completed 52 weeks of treatment. Of these, 70.5% of participants achieved at least well-controlled disease with a urticaria activity score over 7 days (UAS7<=6) by week 52. This exploratory analysis was conducted in the 48 participants who had a UAS7 <6 at week 52 and UAS7 scores at week 76.

At study entry, 70.9% of these patients had severe disease, however, at week 52, 87.3% had a complete response to treatment and 12.7% had well-controlled urticaria. An additional 28 weeks after receiving their last dose, at least mild disease was apparent in 81% of participants with 50% having a complete response and 18.8% having well-controlled disease. The researchers found that the prolonged, off-treatment efficacy was maintained despite clearance of barzolvolimab and normalization of serum tryptase, a mast cell biomarker. Half of the participants had continuous, well-controlled disease with mean(SD) UAS7 0.4(1.1); mean(SD) Dermatology Life Quality Index (DLQI) 1.17(3.50) and 83.3% DLQI of 0/1 (no impact of disease on quality of life) at week 76.

Because of the prolonged off-treatment efficacy observed 28 weeks after the last dose of barzolvolimab, researchers suggest a potential disease modification.

Visit aaaai.org to learn more about urticaria. Research presented at the 2026 AAAAI Annual Meeting, February 27 – March 2 in Philadelphia, PA, is published in an online supplement to The Journal of Allergy and Clinical Immunology (JACI).

The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists and other professionals with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI is the go-to resource for patients living with allergies, asthma and immune deficiency disorders.

SOURCE American Academy of Allergy, Asthma & Immunology (AAAAI)