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A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2024

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At a glance

  • Drugs Stapokibart (Primary)
  • Indications Nasal polyps; Rhinosinusitis
  • Focus Registrational; Therapeutic Use
  • Acronyms CROWN-2
  • Sponsors KeyMed Biosciences

    • Most Recent Events

    • 23 Dec 2024 According to Keymed Biosciences media release, company announced the National Medical Products Administration of China has recently approved the supplemental New Drug Application Stapokibart for the treatment of chronic rhinosinusitis with nasal polyposis based on this study.
    • 08 Nov 2024 Status changed from recruiting to completed.
    • 27 Aug 2024 According to Keymed Biosciences media release, the new drug application of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) was accepted by the NMPA and granted priority review.

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