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A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years

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A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2025

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At a glance

  • Drugs Remibrutinib (Primary)
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 11 Apr 2025 Planned End Date changed from 4 Feb 2032 to 30 Mar 2032.
    • 11 Apr 2025 Planned primary completion date changed from 20 Nov 2025 to 2 Apr 2026.
    • 04 Sep 2024 Planned End Date changed from 22 Jan 2032 to 4 Feb 2032.

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