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A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis

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Trial Profile

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 19 Jan 2024

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At a glance

  • Drugs Birtamimab (Primary)
  • Indications Amyloid light-chain amyloidosis
  • Focus Registrational; Therapeutic Use
  • Acronyms VITAL
  • Sponsors Onclave Therapeutics; Prothena

    • Most Recent Events

    • 12 Dec 2023 Results of pooled analysis of phase 1-3 studies ((NCT01707264) with open-label extension (OLE; NCT02613182) and 2 RCTs (Phase 2 PRONTO with OLE [NCT03154047] and Phase 3 VITAL)) assessing safety from birtamimab, presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 27 Jun 2023 Results published in the Blood.
    • 27 Jun 2023 According to a Prothena media release, data from post hoc analysis of this study presented in Blood, a journal of the American Society of Hematology (ASH).

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