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A Multi-center, Randomized, Double-blind, Active and Placebo-controlled Study to Investigate the Safety and Efficacy 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 Safety and Efficacy 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: 29 Nov 2023

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At a glance

  • Drugs Ligelizumab (Primary) ; Omalizumab
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Acronyms Pearl 1
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharma A.G.; Novartis Pharmaceuticals

    • Most Recent Events

    • 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.
    • 27 Feb 2023 Results assessing eficacy and safety of ligelizumab from PEARL-1 and PEARL-2 studies were presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 28 Jul 2022 Status changed from active, no longer recruiting to completed.
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