This is a Phase 3 multi-center, open-label, single arm study investigating the safety, tolerability and efficacy of remibrutinib in participants with CSU inadequately controlled by second generation H1-antihistamines. Inadequate control of CSU by second generation H1-antihistamines is defined as:~The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period~Urticaria Activity Score (UAS7) score (range 0-42) ≥ 16, Itch Severity Score (ISS7) score (range 0-21) ≥ 6 and Hives Severity Score (HSS7) score (range 0-21) ≥ 6 during the 7 days prior to baseline (Day 1).~The study consists of three periods, the total study duration is up to 60 weeks: screening period of up to 4 weeks, open-label treatment period of 52 weeks, and a treatment free follow-up period of 4 weeks.
The purpose of this study is to evaluate the safety and efficacy of remibrutinib (LOU064) in adult Japanese chronic spontaneous urticaria (CSU) participants inadequately controlled by second generation H1-antihistamines.