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A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobact

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobact

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Amikacin (Primary) ; Azithromycin; Ethambutol
  • Indications Lung disorders; Mycobacterium avium complex infections; Nontuberculous mycobacterium infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ENCORE
  • Sponsors Insmed

    • Most Recent Events

    • 22 Feb 2024 According to an Insmed Incorporated media release, The Data Safety Monitoring Committee for the ENCORE study held its third safety review meeting in November 2023 and recommended that the study continue as planned. This trial is designed to satisfy the PMDA's remaining regulatory requirements, including the enrollment of Japanese patients, sufficient treatment exposure, and an endpoint for durable culture conversion.
    • 07 Jan 2024 Planned number of patients changed from 250 to 400.
    • 05 Jan 2024 According to an Insmed Incorporated media release, as expected, company will seek a meeting with the Agency in the coming months to gain additional insights and guidance, from which it will finalize its statistical plans for the Phase 3 ENCORE study, including an updated enrollment target for the study.
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