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A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)

Trial Profile

A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2023

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At a glance

  • Drugs Mepolizumab (Primary) ; Mometasone
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SYNAPSE
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK
  • Most Recent Events

    • 01 Apr 2023 Results of post hoc analysis assessing treatment responses and association with patient characteristics. The proportion of patients meeting any and each of five response criteria indicating improvement in disease-specific quality of life, NP size, nasal obstruction, loss of smell, and overall symptoms at Weeks 24 and 52, were assessed in subgroups: 1) no surgery; 2) neither surgery nor systemic corticosteroids (SCS) published in the Rhinology
    • 27 Feb 2023 Results of post hoc analysis assessing the changes from baseline in peak nasal inspiratory fliw at week 52 and proportions of PRO responders at week 49-52, among patients with greater than equal to 1 point versus no (less than 1 point) week 52 improvemnet in NPS, presented at the 2023 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 14 Nov 2022 Results presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology
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