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A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants With Genetically Diagnosed Spinal Muscular Atrophy

Trial Profile

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants With Genetically Diagnosed Spinal Muscular Atrophy

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2026

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At a glance

  • Drugs BIIB 115 (Primary)
  • Indications Spinal muscular atrophy
  • Focus Adverse reactions; Registrational
  • Acronyms STELLAR-2
  • Sponsors Biogen

Most Recent Events

  • 11 Mar 2026 According to Biogen media release, this trial is planned to be initiated in Q3 2026.
  • 11 Mar 2026 According to Biogen media release, trial design of the Phase 3 salanersen clinical trial program were presented at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference. It will also be shared at the 5th International Scientific Congress on SMA (SMA Europe 2026).
  • 06 Mar 2026 New trial record

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