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A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

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Trial Profile

A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ≥ 12 Years With Severe Hemophilia A or B With or Without Inhibitory Antibodies to Factor VIII or IX

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

Latest Information Update: 16 Oct 2025

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At a glance

  • Drugs Fitusiran (Primary) ; Damoctocog alfa pegol; Factor VIII; Factor VIII inhibitors
  • Indications Haemophilia A; Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-NEO
  • Sponsors Sanofi

Most Recent Events

  • 10 Oct 2025 Planned primary completion date changed from 12 Sep 2026 to 15 May 2027.
  • 28 Mar 2025 According to Sanofi Media Release, the US FDA approved Qfitlia (fitusiran), as the first therapy in the US to treat hemophilia A or B with or without inhibitors based on the data from this trail along with other ATLAS trials.
  • 21 Oct 2024 Planned End Date changed from 1 Mar 2028 to 1 Jun 2028.

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