NCT06246513

A Phase 3 Multinational, Open-label, Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9003 in Subjects With Limb Girdle Muscular Dystrophy 2E/R4

Study Summary

This is a multicenter, global study of the effects of a single systemic dose of SRP-9003 on beta-sarcoglycan (β-SG) gene expression in participants with limb-girdle muscular dystrophy, type 2E/R4 (LGMD2E/R4). This study will consist of both ambulatory participants (Cohort 1) and non-ambulatory participants (Cohort 2).

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Interventions

SRP-9003BIOLOGICAL
Solution for single IV infusion
GlucocorticoidDRUG
Oral tablet (prophylactic)

Study Locations

FacilityCityStateCountry
University of California, San Diego-Altman Clinical and Translational Research InstituteLa JollaCaliforniaUnited States
Nationwide Childrens HospitalColumbusOhioUnited States
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Children's Hospital of The King's DaughterNorfolkVirginiaUnited States
University Hospital Leuven (UZ Leuven)LeuvenVlaams BrabantBelgium
NMRC Gent (UZ Gent)GhentBelgium
Universitatsklinikum Essen; Kinderklinik I, Sozialpadiatrisches ZentrumEssenNorth Rhine-WestphaliaGermany
Fondazione IRCCS Ca Granda Ospedale Maggiore PoliclinicoMilanItaly
Hospital Sant Joan de DeuBarcelonaSpain
Newcastle UniversityNewcastle upon TyneUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026