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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2026

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At a glance

  • Drugs Remibrutinib (Primary)
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Acronyms REMIX-1
  • Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 27 Jul 2026 According to a Novartis media release, Health Canada has issued a Notice of Compliance (NOC) for RHAPSIDO (remibrutinib tablets) for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.1 The decision is supported by the phase III REMIX-1 and REMIX-2 double-blind, randomized, placebo-controlled studies.
  • 21 Jul 2026 According to a Novartis media release, Japan's MHLW approved Rhapsido as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) with inadequate response to H1-antihistamine treatment.
  • 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)

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