Celldex Therapeutics’ barzolvolimab demonstrated improved disease control and quality of life in Phase 2 studies of patients with chronic spontaneous urticaria and chronic inducible urticaria (CIndU).

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.

The data, which was presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, showed that 82% of CSU patients reported that symptoms no longer had an impact on their quality of life at Week 52, and 60% of CIndU patients reported that symptoms no longer had an impact on their quality of life at Week 12.

Now, global Phase 3 studies are actively enrolling for barzolvolimab in patients with CSU (EMBARQ-CSU1 and EMBARQ-CSU2). Celldex plans to advance barzolvolimab into Phase 3 development for CIndU in 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,” says Martin Metz, MD, Deputy Director, Head of Translational Research at Charité – Universitätsmedizin Berlin in a news release. “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.”

Phase 2 CSU trial disease control and quality of life measurements (52-week analysis)

• Up to 71% of patients with CSU achieved complete response (The Urticaria Activity Score [UAS7] = 0) at Week 52
• Rapid and sustained improvement in urticaria control via  the Urticaria Control Test (UCT)and quality of life via  the Dermatology Life Quality Index (DLQI) observed in patients with CSU refractory to antihistamines
• Up to 82% of patients reported that CSU symptoms no longer had an impact on their quality of life at Week 52
• Up to 95% of patients reported meaningful improvement in quality of life based on DLQI at Week 52.
• Up to 82% of patients reported well-controlled urticaria based on UCT, and approximately half of patients reported complete control at Week 52

Phase 2 CIndU trial disease control and quality of life measurements (12-week analysis)

• Up to 53% of patients with cold urticaria and 58% of patients with dermographism urticaria achieved complete response (negative provocation test.
• Marked and rapid improvement in urticaria control (UCT) and quality of life (DLQI) in patients with ColdU and SD; sustained through the 12-week period
• Up to 60% of patients reported that CIndU symptoms no longer had an impact on their quality of life at Week 12
• Up to 69% of patients reported well-controlled urticaria based on UCT at Week 12

PHOTO CREDIT: DermNet