The discontinuation comes after the study failed to achieve its primary and key secondary objectives
Suboptimal Clinical Outcomes
The 24-week, double-blind, placebo-controlled study enrolled 140 participants with moderate to severe symptoms who lacked adequate responses to topical medications
The trial’s primary goal was to observe a four-point or greater improvement on the worst itch numeric rating scale at the 12-week mark
The percentage of patients reaching this milestone showed no meaningful differentiation from the placebo group
Secondary targets, including the investigator global assessment for skin lesions, were equally unsuccessful. Furthermore, extending the active treatment and evaluation period to 24 weeks yielded no additional clinical improvements
Biological Impact And Safety Profile
Barzolvolimab is a novel humanized monoclonal antibody designed to target and deplete mast cells
The treatment successfully triggered a rapid, profound, and sustained reduction in circulating tryptase, clearly confirming systemic mast cell depletion
However, this biological response did not translate into symptom relief, leading researchers to conclude that mast cells may not be the central pathogenic driver of prurigo nodularis
Despite the lack of clinical efficacy, the drug remained extremely well-tolerated
The administered regimen, featuring an initial 450mg loading dose followed by ongoing 150mg or 300mg doses every four weeks, maintained a favorable safety profile consistent with previous clinical observations
Following the main phase, patients were monitored for an additional 16 weeks, though the primary investigation is now halted
In August 2025, Celldex stopped developing barzolvolimab in eosinophilic esophagitis (EoE) as the drug did not improve EoE symptoms or endoscopic assessment of disease activity compared to placebo
CLDX Price Action: Celldex Therapeutics shares were down 6.06% at $33.50 during premarket trading on Wednesday
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