Celldex Begins Phase 2 Trial of Barzolvolimab for Atopic Dermatitis

HAMPTON, N.J., Dec. 19, 2024 - Celldex Therapeutics, Inc., a prominent player in biotechnology, has commenced a Phase 2 clinical trial to assess the efficacy of barzolvolimab in treating atopic dermatitis (AD). This condition, affecting up to 20% of the U.S. population, is a chronic inflammatory skin disorder that severely impacts quality of life. The study is now actively enrolling participants.

Atopic dermatitis, marked by chronic skin inflammation, represents a significant medical challenge due to its prevalence and impact on patients’ lives. Mast cells, which are heavily involved in AD's pathophysiology, have a role in processes such as immune cell recruitment and neuroinflammation. They are also found in larger numbers in the affected skin tissues of AD patients. Barzolvolimab, a humanized monoclonal antibody, targets the receptor tyrosine kinase KIT, a crucial component for mast cell functionality and survival, thereby inhibiting their activity.

Dr. Diane C. Young, Senior Vice President and Chief Medical Officer at Celldex Therapeutics, emphasized the urgent need for new treatments for AD. Current first-line systemic therapies fail to achieve complete control in about two-thirds of patients, highlighting the need for alternatives that provide rapid relief from severe symptoms like intense itching. Celldex is hopeful that barzolvolimab, with its mast cell depleting properties, will significantly benefit patients by addressing the core of the disease and improving their quality of life.

The ongoing Phase 2 trial is designed as a randomized, double-blind, placebo-controlled study to investigate the safety and effectiveness of barzolvolimab administered subcutaneously in patients with moderate to severe AD. The trial plans to enroll approximately 120 patients, who will be randomly assigned to receive barzolvolimab at doses of either 150 or 300 mg, or a placebo, every four weeks. This follows an initial loading dose of 450 mg or placebo during the first 16 weeks of treatment. Patients in the placebo group will be reassigned to one of the active treatment arms after 16 weeks. Subsequently, all participants will receive the active treatment for another 16 weeks.

The primary goal of the study is to evaluate the clinical efficacy of barzolvolimab by comparing the two dosage levels against a placebo, using the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16. This scale is a reliable tool for assessing the worst itch intensity in adults with moderate-to-severe AD. Secondary outcomes will measure barzolvolimab’s efficacy across various patient-reported metrics, including disease severity, change over time, and quality of life improvements. The study is set to involve up to 50 clinical trial centers across the U.S.

Atopic dermatitis is a prevalent, persistent skin disorder characterized by itchy, red lesions that can evolve into a more chronic, lichenified form due to continuous skin remodeling and scratching. About half of adult AD sufferers have moderate to severe symptoms, with a significant majority experiencing daily itching. The condition often coexists with other allergic disorders like asthma and rhinitis, where mast cells similarly contribute to disease pathology. Celldex recognizes the unmet demand for effective AD treatments, and, given barzolvolimab’s potential, considers it a critical focus for their research.

AD patients can learn more about participating in this trial by visiting clinical trial registries for additional information. Through this study, Celldex aims to deliver progressive therapeutic solutions, leveraging their expertise in mast cell biology to address severe inflammatory and autoimmune disorders.