Celldex Therapeutics, Inc. announced  positive data on measurements of disease control and quality of life from the Company’s Phase 2 barzolvolimab studies in patients with chronic urticaria. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival.

In a Phase 2 chronic spontaneous urticaria (CSU) study (52 week analysis) and a Phase 2 chronic inducible urticaria (CIndU) study (12 week analysis), barzolvolimab demonstrated rapid and sustained improvement in urticaria control and greatly reduced disease impact on quality of life, as measured by the Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI). The data were presented by Martin Metz, M.D., Deputy Director, Head of Translational Research at Charité - Universitätsmedizin Berlin in poster presentations (CSU #L11, CIndU #183) as part of the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2025.

“Patients suffering with chronic urticaria have symptoms which severely impact their daily lives for years or even decades—often with devastating impacts on their quality of life—and treatment options are very limited,” said Martin Metz, MD, Deputy Director, Head of Translational Research at Charité - Universitätsmedizin Berlin. “Barzolvolimab has demonstrated its potential to completely change the treatment paradigm and enable patients to live normally again. We are especially excited to see these meaningful improvements consistently across patients with both CSU and CIndU in large clinical studies.”

The quality of life impairment that patients with CSU experience have been well studied and shown to impact many aspects of life including daily activities, work performance, sleep quality, social functioning and relationships, and mental health, which can manifest as depression, anxiety and suicidal ideation. A recent multi-national patient survey found that the majority of patients report a moderate to high impact from CSU on their daily life. Current clinical guidelines recommend complete disease control as the goal of treatment⁶, and several published analyses have shown that patients have minimal or no impact on their quality of life when they are able to achieve complete disease control.