Barzolvolimab Improves Urticaria Control, Quality of Life in Chronic Inducible Urticaria

New findings suggest cold urticaria (ColdU), a form of chronic inducible urticaria (CIndU), may produce statistically significant and clinically meaningful improvements in disease control and quality of life with barzolvolimab therapy at 20 weeks of use.1

These phase 2 findings on barzolvolimab were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting in Philadelphia, Pennsylvania. The trial investigators, including Jonathan Bernstein, MD, adjunct professor of internal medicine at the University of Cincinnati College of Medicine, describe CIndU as a mast cell–mediated disorder marked by recurrent wheals and pruritus arising in response to specific physical triggers.

The team pointed to those with ColdU as reporting symptoms following exposure to low temperatures, whereas in symptomatic dermographism (SD), lesions tend to develop following friction or stroking of the skin. In Bernstein et al’s randomized, double-blind, placebo-controlled trial (NCT05405660), they assessed the efficacy and safety of barzolvolimab in individuals with ColdU or SD whose disease remained inadequately controlled despite the use of antihistamines.

Earlier findings from the analysis had suggested barzolvolimab significantly increased complete response rates, defined by negative provocation testing, over the course of 20 weeks, while maintaining a favorable safety profile. In Bernstein and colleagues’ present analysis, they looked at disease control and quality of life outcomes through the 20-week mark. There were 97 participants with ColdU and 99 with SD who were randomly assigned to be treated subcutaneously with barzolvolimab at 150 mg on an every-4-week basis, 300 mg every 8 weeks, or placebo for 20 weeks, followed by a 24-week observation period.

Bernstein and coauthors evaluated disease control via the Urticaria Control Test (UCT), and dermatology-specific quality of life was measured through the use of the Dermatology Life Quality Index (DLQI). Outcomes assessed by the investigative team included shifts from baseline (CFB) in subjects’ UCT scores and the proportion of subjects attaining DLQI scores of 0 or 1 at Week 20, suggesting a lack of impact on their quality of life.

Effect on Barzolvolimab on Urticaria Control

Among those with ColdU, baseline mean UCT scores showed a range between 4.9 - 5.8, while baseline DLQI scores ranged from 12.6 - 14.1, reflecting substantial disease burden.1 At the 20-week mark, Bernstein et al found the mean improvement in UCT scores was 8.0 in the 300 mg every-8-weeks arm of the analysis (P = .0001) and 6.4 in the 150 mg every-4-weeks arm (P = .0025), compared with 3.1 in the placebo arm. Regarding quality of life, 61% of those on 300 mg (P = .001) and 60% of those on 150 mg (P = .0018) attained DLQI scores of 0 or 1 at 20 weeks, versus 20% in the placebo arm.

In the SD cohort of the study, Berstein and colleagues found baseline mean UCT scores ranged from 5.3 - 5.5, and DLQI scores from 13.0 - 14.1.1 By the 20-week mark, mean shifts in UCT were 7.1 with 300 mg every 8 weeks (P < .0001) and 6.3 with 150 mg every 4 weeks (P < .0001). This was compared with 2.2 in the placebo cohort. DLQI scores of 0 or 1 were observed among 54% of individuals in the 300 mg cohort (P = .0023) and 45% of those in the 150 mg cohort (P = .0108), as opposed to 12.5% of those on placebo.

Safety findings were also shown to be reassuring, with discontinuations due to adverse events (AEs) seen in 2% of participants given barzolvolimab and 3% of those on placebo.1 Most AEs were also shown to be mild in severity. AEs noted in more than 10% of participants in any treatment arm through Week 20 included hair color changes (18%) and neutropenia (12%). Neutropenia was transient and not found to be linked to increased infections. Hair color alterations and skin hypopigmentation resolved following treatment cessation.

In their conclusion, Bernstein and coauthors describe the study as representing the first large-scale, randomized, placebo-controlled trial to demonstrate clear clinical benefit in CIndU. Overall, barzolvolimab produced statistically significant and clinically meaningful improvements in both patients’ level of disease control and their quality of life at 20 weeks, suggesting it may offer a rapid and durable therapeutic option for those with antihistamine-refractory ColdU or SD.

References

1. Chaudhry U, Metz M, Bernstein J, et al. Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania.

2. Johnson V. Achieving Chronic Spontaneous and Inducible Urticaria Control With Barzolvolimab, with Martin Metz, MD. HCPLive. March 2, 2025. Accessed March 4, 2026. https://www.hcplive.com/view/achieving-chronic-spontaneous-inducible-urticaria-control-barzolvolimab-metz.