A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)
← catalyst calendarNCT06555419 · readout in 309 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →. With Alcyone Therapeutics, Inc.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
58estimated
Sites
19
Countries
France, Germany, Italy +4
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 | 2025-01-16 | actual | When the study began enrolling |
| Primary completion | 2027-06-25 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-25 | estimated | The whole study's end, after follow-up |
| First posted | 2024-08-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-18 | 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
Interventions
- Drug: Nusinersen — also filed as BIIB058
- Device: ThecaFlex DRx System
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Concentration (Cmax) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx System
measured Pre-dose and at multiple time points post-dose up to 4 months
Area Under the Plasma Concentration-Time Curve From Zero Time to 24 Hours After Intrathecal Administration (AUC0-24h) of Nusinersen Delivered via Standard LP and via ThecaFlex DRx System
measured Pre-dose and at multiple time points post-dose up to 4 months
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