Celldex (CLDX) announced the initiation of its global Phase 3 trial designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria, ColdU, and symptomatic dermographism, SD, who remain symptomatic despite H1 antihistamine treatment. ColdU and SD are characterized by the occurrence of hives or wheals that have an attributable trigger associated with them-exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. 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.
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