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A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

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Trial Profile

A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

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

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Tofersen (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS
  • Sponsors Biogen

Most Recent Events

  • 07 Mar 2025 Status changed from recruiting to active, no longer recruiting.
  • 04 Mar 2025 According to a Biogen media release, based data from VALOR trial, Health Canada has issued marketing authorization with conditions (NOC/c)) for QALSODY (tofersen injection) for the treatment of ALS in adults who have a mutation in (SOD1) gene.The authorization is conditional, pending the results of trials to verify its clinical benefit.The final OLE clinical report, summary of integrated analyses with VALOR trial, and results of ATLAS study will serve as the confirmatory trials.
  • 28 Apr 2023 Planned primary completion date changed from 7 Aug 2026 to 7 Aug 2027.

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