Real-World Study of Remibrutinib for Adults With Chronic Spontaneous Urticaria in the US Observing Effectiveness and Safety Over 24 Months

What this Trial Is About

Researchers are evaluating remibrutinib, a new treatment option for patients with Chronic Spontaneous Urticaria CSU, in a prospective, non-interventional study. The study focuses on patients whose treatment plan before joining has already been decided to either increase their current sgH1-AH treatment or switch to remibrutinib. This US sub-study is part of a larger global program called REASSERT, which aims to collect real-world effectiveness and safety data on remibrutinib in typical clinical settings. The study observes patients divided into three groups based on their treatment history and decisions those escalating their current licensed sgH1-AH dose due to inadequate control, those switching to remibrutinib after inadequate control despite licensed or escalated sgH1-AH doses, and those switching to remibrutinib after other treatments in addition to H1-AH. Treatment decisions are made independently of the study. No interventions are assigned by the study, as it is observational. Participants will be followed for up to 24 months, during which researchers will collect data on disease control using UAS7 and UCT7 scores at 12 weeks and throughout the study. Other measures include angioedema activity, use of rescue medications, quality of life questionnaires, healthcare resource use, and adverse events. Patients will provide information electronically, and the study will evaluate treatment patterns, adherence to guidelines, and long-term outcomes.

Remibrutinib in Real-world Clinical Practice - a US Sub-study