NCT05693142

A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Intravenous RGX-202 Gene Therapy in Males With Duchenne Muscular Dystrophy (DMD)

Study Summary

RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain. This is a multicenter, open-label dose evaluation clinical study to assess the safety, tolerability, and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in participants with Duchenne. For additional information on how to participate (or be considered for the study), please follow this link: https://mytomorro.ws/affinity-ct-gov

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Interventions

RGX-202GENETIC
RGX-202 is a recombinant AAV8 containing a transgene encoding a novel microdystrophin

Study Locations

FacilityCityStateCountry
Arkansas Children's HospitalLittle RockArkansasUnited States
Stanford School of Medicine /Division of Neuromuscular MedicinePalo AltoCaliforniaUnited States
Children's Hospital ColoradoAuroraColoradoUnited States
University of FloridaGainesvilleFloridaUnited States
Rare Disease ResearchAtlantaGeorgiaUnited States
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinoisUnited States
University of IowaIowa CityIowaUnited States
University of Massachusetts Chan Medical SchoolWorcesterMassachusettsUnited States
Cincinnati Children'sCincinnatiOhioUnited States
Oregon Health & Science UniversityPortlandOregonUnited States
The University of Texas Southwestern Medical CenterDallasTexasUnited States
Children's Hospital of the King's DaughtersNorfolkVirginiaUnited States
Children's Hospital of Richmond at Virginia Commonwealth UniversityRichmondVirginiaUnited States
Alberta Children's HospitalCalgaryAlbertaCanada
BC Children's HospitalVancouverBritish ColumbiaCanada
Children's Hospital London Health Science CentreLondonOntarioCanada
Children's Hospital of Eastern OntarioOttawaOntarioCanada

Official Trial Information

View on ClinicalTrials.gov

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