A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

Summary

The purpose of this study was to evaluate the safety, tolerability and efficacy of remibrutinib (LOU064) in adult Japanese patients chronic spontaneous urticaria (CSU), who remain symptomatic despite treatment by H1-antihistamine (H1-AH) at locally label approved doses, for a duration of 52 weeks of treatment with remibrutinib and a post-treatment follow-up period of up to 4 weeks.

Timeline

Start

2022-01-15

Primary completion

2023-12-08

Completion

2023-12-09

Publications

• Hayama K, Chinuki Y, Yagami A, Kume A, Morita A, Miyazu S, Lheritier K, Jaskiewicz L, Haemmerle S, Hide M. Remibrutinib Showed a Favorable Safety Profile and Sustained Efficacy in Japanese Patients with Chronic Spontaneous Urticaria Over 52 Weeks. Dermatol Ther (Heidelb). 2026 Mar;16(3):1707-1721. doi: 10.1007/s13555-026-01666-5. Epub 2026 Feb 19.

Drugs

Indications