A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)
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Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
30estimated
Sites
11
Countries
Australia, Brazil, China +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-28 | actual | When the study began enrolling |
| Primary completion | 2028-11-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2032-05-29 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Muscular Atrophy, Spinal
Intervention
- Drug: Salanersen — also filed as BIIB115
Primary outcomes
what the primary-completion date above is the date OFPart 1: Percentage of Participants with 2 Survival Motor Neuron 2 (SMN2) Copies Sitting Without Support (for at Least 10 Seconds)
measured At Month 12
Part 1: Percentage of Participants with 3 SMN2 Copies Walking Alone (for at Least 5 Steps)
measured At Month 18
Part 2: Percentage of Participants Attaining and Maintaining World Health Organization (WHO) Motor Milestones
measured Up to Day 1825
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