Celldex: Barzolvolimab Achieves All Endpoints in Phase 2 Chronic Inducible Urticaria Study

Celldex Therapeutics, Inc. has announced promising results from its Phase 2 clinical trial of barzolvolimab for treating chronic inducible urticaria (CIndU), including cold urticaria (ColdU) and symptomatic dermographism (SD). This trial focuses on patients who continue to experience symptoms despite using antihistamines. Barzolvolimab, a humanized monoclonal antibody, specifically targets the receptor tyrosine kinase KIT, crucial for mast cell function and survival. The study's results were unveiled at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Boston by Dr. Jonathan Bernstein.

CIndU is characterized by hives triggered by specific factors—cold exposure for ColdU and skin friction for SD. Mast cell activation plays a key role in these conditions. Barzolvolimab's efficacy was demonstrated in a significant, randomized, placebo-controlled study, achieving all primary and secondary endpoints with high statistical significance and clinical relevance. Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics, remarked on the drug's potential to significantly improve patient outcomes and the company's plans to advance to Phase 3 development in 2025.

The trial's primary efficacy endpoint was a statistically significant difference in the percentage of patients with a negative provocation test at Week 12 compared to a placebo, assessed using TempTest® for ColdU and FricTest® for SD. All secondary endpoints were also met, including responder analyses and improvements in critical temperature and friction thresholds, itch severity associated with provocation tests, and Urticaria Control Test scores.

The study involved 196 patients with CIndU unresponsive to antihistamines, with 193 completing the full analysis. A high completion rate of 90% was observed, with balanced demographics and baseline characteristics across treatment groups. In ColdU patients, the baseline critical temperature was approximately 19°C (66°F), while SD patients had a mean baseline FricTest score of 3.6 out of 4 pins, indicating poorly controlled disease at the outset.

At Week 12, significant improvements were observed in both ColdU and SD patients treated with barzolvolimab compared to placebo. For ColdU patients, 46.9% and 53.1% of those receiving barzolvolimab at 150 mg every four weeks and 300 mg every eight weeks respectively had a negative provocation test, compared to 12.5% in the placebo group. Similarly, for SD patients, substantial improvements were seen, with 57.6% and 42.4% showing complete response compared to 3.2% in the placebo group.

The drug's safety profile was favorable, with most adverse events being mild (grade 1). Common side effects included hair color changes and neutropenia, which are expected to be reversible. Infection rates were comparable between barzolvolimab-treated patients and placebo, with no link between neutropenia and infections.

Barzolvolimab is being studied for various conditions, including chronic spontaneous urticaria, prurigo nodularis, and eosinophilic esophagitis, with potential future applications in atopic dermatitis. The Phase 2 CIndU study is a double-blind, placebo-controlled trial involving 196 patients with ColdU and SD, evaluating the efficacy and safety of two dosage regimens of barzolvolimab. The primary endpoint is the percentage of patients with a negative provocation test at Week 12, with secondary endpoints including safety and other clinical activity measures.

Chronic inducible urticaria affects approximately 0.5% of the population, with no approved therapies beyond antihistamines. Patients often manage symptoms by avoiding triggers. Celldex Therapeutics is at the forefront of developing transformative therapeutics for severe inflammatory, allergic, autoimmune, and other serious diseases.

 

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