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A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Profile

A Phase III, Randomized, Multi-Center, Open-Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2024

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At a glance

  • Drugs Pegcetacoplan (Primary) ; Eculizumab
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms PEGASUS
  • Sponsors Apellis Pharmaceuticals

    • Most Recent Events

    • 12 Dec 2023 Results of an integrated analysis assessing long-term efficacy and safety of pegcetacoplan for PNH treatment from following clinical trials: PEGASUS, PRINCE and their extension trials presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 11 Dec 2023 According to an Apellis Pharmaceuticals media release, post hoc data from PEGASUS and PRINCE studies and the long-term extension study that reinforce the long-term efficacy and safety of EMPAVELI were presented during an oral presentation at the American Society of Hematology (ASH) Annual Meeting.
    • 14 Sep 2023 Results assessing ISR incidence and severity with longer-term treatment in the PEGASUS cohort of the Study 307 open-label extension (307 OLE) published in the Advances in Therapy
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