Celldex initiates global Phase 3 program for barzolvolimab in CSU

Celldex Therapeutics announced the initiation of its global Phase 3 program, consisting of two Phase 3 trials designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies will also include patients who remain symptomatic after treatment with biologics. For patients with CSU, the activation of mast cells in the skin results in episodes of itchy hives, swelling and inflammation of the skin that can severely impact their daily lives for years or even decades. Treatment options are limited, particularly for patients not adequately controlled by omalizumab. Barzolvolimab, a novel monoclonal antibody, works upstream of other treatment approaches for CSU, targeting the root driver of the disease-mast cells-by blocking the receptor tyrosine kinase KIT, which is required for mast cell function and survival. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. Both Phase 3 trials are randomized, double-blind, placebo-controlled, parallel group, global studies where approximately 915 patients will be randomized evenly to barzolvolimab 150 mg every 4 weeks, barzolvolimab 300 mg every 8 weeks or placebo for 52 weeks. At 24 weeks, patients on placebo will be re-randomized to active treatment across both dosing groups. The primary endpoint of the study will evaluate the clinical effect of barzolvolimab in reducing urticaria activity at Week 12. The study is designed to detect a clinically meaningful difference between each of the active arms vs placebo in the overall population as well as in the subpopulation of omalizumab refractory participants.