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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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Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2026

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At a glance

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

Most Recent Events

  • 20 Jul 2026 Planned primary completion date changed from 6 Nov 2026 to 3 Nov 2026.
  • 20 Jul 2026 Status changed from recruiting to active, no longer recruiting.
  • 14 Apr 2026 Planned primary completion date changed from 2 Apr 2026 to 6 Nov 2026.

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