Chronic spontaneous urticaria (CSU) is a skin disease mainly driven by the activation of cutaneous mast cells by various mechanisms including autoantibodies. Bruton's tyrosine kinase (BTK), expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes. The efficacy and safety of rilzabrutinib (SAR444671), an oral reversible covalent BTK inhibitor, is being evaluated in adults with moderate-to-severe CSU.