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A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

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Trial Profile

A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 May 2024

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At a glance

  • Drugs Dupilumab (Primary)
  • Indications Nasal congestion; Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SINUS-52
  • Sponsors Regeneron Pharmaceuticals; Sanofi
  • Most Recent Events

    • 14 May 2024 According to Regeneron Pharmaceuticals media release, Regeneron and Sanofi today announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled CRSwNP. sBLA in adolescents is supported by an extrapolation of efficacy data from 2 pivotal trials SINUS24 and SINUS52
    • 01 Dec 2023 Results of pooled analysis (n=688 from NCT02912468 and NCT02898454) assessing the relationship of sinus opacification, olfaction and dupilumab efficacy in patients with CRSwNP published in the Rhinology
    • 18 May 2022 Results of (SYNAPSE [mepolizumab], SINUS 24/52 [dupilumab], POLYP 1/2 [omalizumab]) assessing the feasibility of conducting an ITC to obtain unbiased estimates of the relative efficacy of biologics for treatment of uncontrolled chronic rhinosinusitis with nasal polyps, presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
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