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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: 09 Mar 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 Feb 2026 According to a Novartis media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for remibrutinib. The opinion supports its use as an oral treatment for chronic spontaneous urticaria (CSU) in adult patients with inadequate response to H1-antihistamine treatment. supported by results from the pivotal REMIX-1 and REMIX-2 Phase III trials.
  • 23 Feb 2026 According to a Novartis media release, data from this study will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, PA, from February 27 to March 2, 2026.
  • 30 Sep 2025 According to a Novartis media release, company announced that Rhapsido received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU), this approval is based on results from the Phase III REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157) clinical trials.

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