Trial Profile

A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistamines

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 30 Jul 2026

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At a glance

19 Jun 2026 According to a Novartis media release, company received manufacturing and marketing approval for Lapsid Tablets 25 mg (remibrutinib) based on data from an international collaborative Phase III trial ( Study A2301 , REMIX-1 ), a foreign Phase III trial ( Study A2302 , REMIX-2), and a domestic Phase III trial ( Study A1301 , BISCUIT)
19 Jun 2026 Results presented in the Novartis media release.
06 Feb 2024 Status changed from active, no longer recruiting to completed.

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