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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: 07 Nov 2025

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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

  • 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.
  • 28 Feb 2025 According to a Novartis media release, regulatory submissions for remibrutinib as a treatment for CSU on track for filing in 1H 2025.
  • 28 Feb 2025 According to a Novartis media release, Company will present data from this study at the 2025 American Academy of Allergy Asthma and Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and the 2025 American Academy of Dermatology (AAD) Annual Meeting.

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