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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients with Severe Nasal Polyposis (OSTRO)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients with Severe Nasal Polyposis (OSTRO)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Benralizumab (Primary) ; Mometasone
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms OSTRO
  • Sponsors AstraZeneca

Most Recent Events

  • 09 Nov 2022 Data from 3 studies (NCT03401229, NCT03347279 and NCT03406078) was used to evaluate the changes in patients behavior throughout a longer study with respect to daily Patient-Reported Outcomes were presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
  • 14 Mar 2022 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps. The sBLA included data from this study.
  • 29 Sep 2021 Results published in the Journal of Allergy and Clinical Immunology

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