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A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

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Trial Profile

A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Feb 2025

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At a glance

  • Drugs Dupilumab (Primary) ; Mometasone
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SINUS-24
  • Sponsors Regeneron Pharmaceuticals; Sanofi

Most Recent Events

  • 01 Jan 2025 Post hoc analysis results investigating the effect of dupilumab on olfaction using UPSIT smell impairment categories, were published in the Current Medical Research and Opinion
  • 13 Sep 2024 According to Regeneron Pharmaceuticals media release,company announced that the U.S.FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps this approval is supported by evidence from two positive pivotal trials (SINUS-24 and SINUS-52) which expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older.
  • 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

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