A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec
← catalyst calendarNCT07444450 · readout in 1,073 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
42estimated
Sites
1
Country
United States
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 | 2026-09-04 | estimated | When the study began enrolling |
| Primary completion | 2029-07-27 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-07-26 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | 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
Interventions
- Drug: Salanersen — also filed as BIIB115
- Procedure: Sham Procedure
Primary outcome
what the primary-completion date above is the date OFParts A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Part A: Up to Day 365
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