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A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

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Trial Profile

A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2022

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Urticaria
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTERIA-II
  • Sponsors Genentech
  • Most Recent Events

    • 14 Nov 2022 Results of post-hoc analysis pooled from ASTERIA I and ASTERIA II trials presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology
    • 02 Nov 2016 Results of pooled analysis of two phase III studies (ASTERIA I and ASTERIA II) presented at the 19th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 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
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