Real-world Study of Remibrutinib for Treating Chronic Spontaneous Urticaria in Adults

What this Trial Is About

Researchers are evaluating remibrutinib in patients with chronic spontaneous urticaria CSU in a prospective, multi-country, non-interventional study. The study focuses on patients where the treatment decision to escalate current second-generation H1-antihistamines sgH1-AHs or switch to remibrutinib was made before enrollment. The goal is to collect real-world data on the effectiveness and safety of remibrutinib across diverse clinical practices, reflecting a broader patient population than typical clinical trials. The study follows an umbrella design allowing adaptations to local treatment guidelines and evidence needs across countries. Patients are grouped into cohorts based on their treatment history and decisions Cohort 1 includes those escalating sgH1-AH treatment due to inadequate control Cohort 2 includes those switching to remibrutinib Cohort 3 covers patients switching to remibrutinib with other prior treatments. Data are collected using tools like the Urticaria Control Test UCT, Urticaria Activity Score over 7 days UAS7, and Dermatology Life Quality Index DLQI. Participants will be monitored for up to 24 months with regular assessments of disease control, quality of life, angioedema activity, treatment patterns, and adverse events. Data will be gathered via electronic patient-reported outcomes and diaries to track symptoms and treatment adherence. The primary outcomes measured are UCT7 and UAS7 scores at 12 weeks after starting remibrutinib, with additional long-term measures to understand treatment effects and patient experiences.

Remibrutinib in Real-world Clinical Practice