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An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria

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Trial Profile

An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2023

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At a glance

  • Drugs Pozelimab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 15 Jun 2023 Results reporting efficacy (LDH) and safety (TEAEs) through weeks 26 (NCT03946748) and long-term efficacy and safety of Pozelimab monotherapy through week 104 (NCT04162470) presented at the 28th Congress of the European Haematology Association
    • 17 May 2023 Status changed from completed to discontinued.
    • 13 Dec 2022 Primary endpoint has been met. (Proportion of patients achieving lactate dehydrogenase (LDH) less than or equal to 1.5ULN), as results presented at the 64th American Society of Hematology Annual Meeting and Exposition.

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