Celldex released 76-week data from a Phase 2 trial of barzolvolimab for chronic spontaneous urticaria (CSU). Seven months after the completion of dosing, a substantial portion of patients continued to experience complete response (no hives or itching) and reported improved quality of life. The data was presented at the EAACI Congress 2025.
These findings are potentially transformative for CSU treatment. Current therapies often only provide temporary relief, and many patients, including those who don’t respond to biologics, struggle to achieve lasting remission. Barzolvolimab’s ability to sustain complete response months after treatment cessation, particularly in patients with severe, refractory disease, suggests a potential paradigm shift in CSU management, offering hope for a disease that significantly impacts patients’ daily lives.
At 76 weeks (7 months post-treatment), 41% of patients treated with barzolvolimab 150mg every four weeks achieved complete response, with 48% reporting no impact of CSU on their quality of life. The 300mg every eight weeks dosage demonstrated similar, although slightly lower, efficacy. Importantly, the safety profile remained favorable throughout the 76-week study, with previously observed mild, reversible side effects related to KIT inhibition.
This data reinforces barzolvolimab’s potential as a best-in-class treatment for CSU. With Phase 3 trials already underway, positive results could pave the way for a significant advancement in how this chronic and often debilitating condition is managed. The potential for long-lasting remission after a finite treatment period could dramatically improve patient outcomes and reduce the burden of long-term CSU management.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
