A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
← catalyst calendarNCT05881408 · readout in 285 d
Sponsored by Sarepta Therapeutics, Inc. (industry) · SRPT — their whole pipeline →. With Hoffmann-La Roche.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
148estimated
Sites
46
Countries
Australia, Belgium, Canada +11
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 | 2023-05-31 | actual | When the study began enrolling |
| Primary completion | 2027-05-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2023-05-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Duchenne Muscular Dystrophy
Interventions
- Genetic: delandistrogene moxeparvovec — also filed as SRP-9001, delandistrogene moxeparvovec-rokl, ELEVIDYS
- Genetic: placebo
Primary outcome
what the primary-completion date above is the date OFPart 1: Change From Baseline in the Total Score of Performance of Upper Limb (PUL) (Version 2.0) at Week 72
measured Baseline, Week 72
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