Chronic Urticarias Treatment
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Celldex Presents Positive Data from Phase 2 Chronic Spontaneous Urticaria and Phase 2 Cold Urticaria and Symptomatic Dermographism Studies Demonstrating Rapid, Profound and Durable Improvements in Patient Quality of Life at AAD 2026
Globenewswire· 2026-03-27 14:30
Core Insights - Celldex presented positive data from Phase 2 clinical trials of barzolvolimab for chronic spontaneous urticaria (CSU), cold urticaria (ColdU), and symptomatic dermographism (SD), showing significant improvements in patient quality of life across various domains [1][2][5] Clinical Efficacy - Barzolvolimab demonstrated a complete response rate of up to 51% at 12 weeks, increasing to 71% at 52 weeks, with 41% of patients remaining symptom-free seven months post-treatment [6] - In a post hoc analysis, 94% of patients with well-controlled disease at Week 52 reported no impact on their quality of life (DLQI score of 0/1) [6] - Significant improvements were observed across all six DLQI domains, indicating a broad beneficial impact on quality of life [5][6] Patient Impact - Chronic urticarias cause severe physical and psychological suffering, with recent literature indicating increased mortality and suicidal ideations among patients with CSU [2] - Barzolvolimab's efficacy translates into dramatic improvements in patient quality of life, offering hope for better management of chronic urticarias [2] Ongoing Research and Development - Celldex has completed enrollment in a global Phase 3 program for CSU, with 1,939 patients enrolled, marking it as the largest program for antihistamine-refractory CSU [10] - The company is also conducting Phase 3 studies for ColdU and SD, with topline data expected in Q4 2026 [10][15] Mechanism of Action - Barzolvolimab is a humanized monoclonal antibody that targets mast cells, which play a central role in the onset and progression of chronic urticarias [13][15]