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A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

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Trial Profile

A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2025

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At a glance

  • Drugs Ligelizumab (Primary) ; Omalizumab
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Acronyms Pearl 2
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharma KK; Novartis Pharmaceuticals

Most Recent Events

  • 23 Nov 2023 Primary endpoint has not been met. (Absolute change from baseline in UAS7 at Week 12 (Ligelizumab 72 mg Vs Omalizumab 300 mg))
  • 23 Nov 2023 Primary endpoint has been met. (Absolute change from baseline in UAS7 at Week 12 ligelizumab 72mg, 120mg vs Placebo)
  • 23 Nov 2023 Results assessing efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria in two phase III trials PEARL-1 and PEARL-2 published in the Lancet.

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