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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: 05 Mar 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

  • 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.
  • 05 Jun 2024 This trial has been completed in Czechia (End date: 2024-01-19) according to European Clinical Trials Database record.

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