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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

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Trial Profile

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2024

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At a glance

  • Drugs Clesrovimab (Primary) ; Palivizumab
  • Indications Respiratory syncytial virus infections
  • Focus Adverse reactions; Registrational
  • Acronyms SMART
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.; MSD KK

    • Most Recent Events

    • 17 Dec 2024 According to a Merck and Co media release, company announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2025. The application is supported by results from the pivotal Phase 2b/3 CLEVER trial and interim results from the ongoing Pha
    • 17 Oct 2024 According to a Merck AG media release, data from this trial were presented during IDWeek 2024, held October 16-19 in Los Angeles, California.
    • 17 Oct 2024 Interim results presented in a Merck AG Media Release.

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