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: 09 Feb 2026

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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

04 Feb 2026 Planned End Date changed from 1 Jun 2028 to 25 Jan 2029.
04 Feb 2026 Planned primary completion date changed from 15 May 2027 to 25 Mar 2027.
10 Oct 2025 Planned primary completion date changed from 12 Sep 2026 to 15 May 2027.

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