A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
← catalyst calendarNCT05575011 · readout in 1,913 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
62actual
Sites
17
Countries
Belgium, Canada, France +6
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 | 2022-10-10 | actual | When the study began enrolling |
| Primary completion | 2031-11-14 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-11-14 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Healthy Volunteer
- Muscular Atrophy, Spinal
Interventions
- Drug: BIIB115
- Drug: BIIB115-Matching Placebo
Primary outcome
what the primary-completion date above is the date OFParts A, B, and B Long Term Extension (LTE): Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured Part A: Up to Day 393, Part B: Up to Day 720; Part B LTE: Up to Day 2520
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