A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)
← catalyst calendarSponsored by Sarepta Therapeutics, Inc. (industry) · SRPT — their whole pipeline →. With Hansa Biopharma AB.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
5actual
Sites
1
Country
Spain
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
Why the sponsor stopped it
Study is being terminated due to a business decision.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-01-29 | actual | When the study began enrolling |
| Primary completion | 2025-10-10 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-10 | actual | The whole study's end, after follow-up |
| First posted | 2024-02-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-20 | 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
- Biological: imlifidase — also filed as Idefirix
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Protein Expression as Measured by Western Blot Adjusted by Muscle Content
measured Baseline, Week 12
Change From Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Expression in Biopsied Muscle as Measured by Immunofluorescence (IF) Fiber Intensity
measured Baseline, Week 12
Change From Baseline in Quantity of Delandistrogene Moxeparvovec Dystrophin Expression in Biopsied Muscle as Measured by IF Percent Dystrophin-positive Fibers (PDPF)
measured Baseline, Week 12
Mean Concentration of Vector Genome Copies Using Polymerase Chain Reaction in Muscle Tissue Biopsy, After Delandistrogene Moxeparvovec Administration
measured Week 12
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