1. Anti‐KIT antibody, barzolvolimab, reduces skin mast cells and disease activity in chronic inducible urticaria.
- Author
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Terhorst‐Molawi, Dorothea, Hawro, Tomasz, Grekowitz, Eva, Kiefer, Lea, Merchant, Kunal, Alvarado, Diego, Thomas, Lawrence J., Hawthorne, Thomas, Crowley, Elizabeth, Heath‐Chiozzi, Margo, Metz, Martin, and Maurer, Marcus
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URTICARIA , *MAST cell disease , *C-kit protein , *CHRONIC diseases - Abstract
Background: Chronic inducible urticaria (CIndU) is characterized by mast cell (MC)‐mediated wheals in response to triggers: cold in cold urticaria (ColdU) and friction in symptomatic dermographism (SD). KIT receptor activation by stem cell factor (SCF) is essential for MC function. Barzolvolimab (CDX‐0159) is a humanized antibody that inhibits KIT activation by SCF and was well tolerated in healthy volunteers with dose‐dependent plasma tryptase suppression indicative of systemic mast cell ablation. Methods: This is an open‐label, trial in patients with antihistamine refractory ColdU or SD, receiving one IV dose of barzolvolimab (3 mg/kg), with a 12‐week follow‐up. Primary endpoint was safety/tolerability; pharmacodynamic (PD)/clinical endpoints included serum tryptase, plasma SCF, skin MC histology, provocation tests, urticaria control test (UCT), and dermatology life quality index (DLQI). Results: Analysis populations were safety (n = 21) and pharmacodynamics/clinical activity (n = 20). Barzolvolimab was well tolerated; most adverse events were mild and resolved. Treatment resulted in significant depletion of skin MCs, decreased tryptase (
- Published
- 2023
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