Remibrutinib versus Omalizumab for Chronic Spontaneous Urticaria Control

This study focuses on finding the best way to treat chronic spontaneous urticaria (CSU) in adults who have not found relief with common allergy medications known as second-generation H1-antihistamines. CSU is a condition that causes itchy hives and swelling on the skin without a known trigger. The study aims to compare the effectiveness and safety of a new drug called Remibrutinib with a commonly used injection treatment called Omalizumab, as well as with a placebo. By understanding how well these treatments work, the study hopes to offer better options for people who struggle with this condition. Participants in the study will go through four different phases over a period of up to 112 weeks. Initially, there is a screening phase to check eligibility and to stop any conflicting medications. During the main treatment phase, participants will be randomly assigned to receive either Remibrutinib tablets or Omalizumab injections, with placebos used to maintain the study's double-blind nature. An optional extension phase allows for further treatment with Remibrutinib for another year. Throughout the study, participants will continue their standard H1-antihistamine treatments and may use additional ones if needed for severe symptoms. Safety follow-ups will be conducted after treatment, ensuring any effects of the medication are closely monitored.