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A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

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Trial Profile

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2018

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At a glance

  • Drugs Omalizumab (Primary) ; Diphenhydramine
  • Indications Urticaria
  • Focus Adverse reactions; Registrational
  • Acronyms GLACIAL
  • Sponsors Genentech

    • Most Recent Events

    • 05 Mar 2018 Results of post hoc analysis examining treatment with omalizumab in subgroups defined by patient demographics with respect to the change from baseline to end of study in whole blood histamine or percentage circulating basophils presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 13 Jul 2016 Results of angioedema prevalence from three pivotal studies (ASTERIA I, ASTERIA II and GLACIAL) published in the Annals of Allergy, Asthma and Immunology
    • 16 Oct 2015 Results assessing response pattern of this and two other trials (ASTERIA-I and ASTERIA-II) published in the Journal of Allergy and Clinical Immunology
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