A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
3actual
Sites
2
Country
France
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 | 2021-11-18 | actual | When the study began enrolling |
| Primary completion | 2025-04-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-08 | actual | The whole study's end, after follow-up |
| First posted | 2025-04-29 | actual | When this record first appeared on the registry |
| Results posted | 2026-04-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-04-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acid Sphingomyelinase Deficiency
Intervention
- Drug: Olipudase alfa — also filed as GZ402665
Primary outcome
what the primary-completion date above is the date OFNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured From the signature of informed consent (Day 0) up to end of safety follow-up per participant, up to approximately 40 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2023-06-01 · 574 KB · Prot_SAP_000.pdf
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