NCT05096221

A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

Study Summary

The study will evaluate the safety and efficacy of gene transfer therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study. The participants who are randomized to the placebo arm will have an opportunity for treatment with gene transfer therapy at the beginning of the second year.

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Interventions

delandistrogene moxeparvovecGENETIC
Single IV infusion of delandistrogene moxeparvovec.
placeboGENETIC
Single IV infusion of matching placebo.

Study Locations

FacilityCityStateCountry
Arkansas Children'sLittle RockArkansasUnited States
UC San Diego Altman Clinical and Translational Research InstituteLa JollaCaliforniaUnited States
UCLA Medical CenterLos AngelesCaliforniaUnited States
Lucile Packard Children's Hospital at StanfordPalo AltoCaliforniaUnited States
University of California, DavisSacramentoCaliforniaUnited States
Children's Hospital ColoradoAuroraColoradoUnited States
University of FloridaGainesvilleFloridaUnited States
Lurie Children's Hospital of ChicagoChicagoIllinoisUnited States
University of Iowa Stead Family Children's HospitalIowa CityIowaUnited States
The Johns Hopkins HospitalBaltimoreMarylandUnited States
Boston Children's HospitalBostonMassachusettsUnited States
Washington University of St. LouisSt LouisMissouriUnited States
Columbia University/NYPHNew YorkNew YorkUnited States
University of RochesterRochesterNew YorkUnited States
Duke University Medical Center, Lenox Baker Children's HospitalDurhamNorth CarolinaUnited States
Nationwide Children's HospitalColumbusOhioUnited States
Oregon Health & Science UniversityPortlandOregonUnited States
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States
Vanderbilt University Medical CenterNashvilleTennesseeUnited States
University of Texas SouthwesternDallasTexasUnited States
University of Utah HospitalSalt Lake CityUtahUnited States
Children's Hospital of the King's DaughtersNorfolkVirginiaUnited States
Children's WisconsinMilwaukeeWisconsinUnited States
University Hospital GhentGhentBelgium
LMU - Klinikum der Universitaet Muenchen - Kinderklinik undBayernGermany
Universitätsklinikum Essen - Klinik für Kinderheilkunde IEssenGermany
University Hospital Hamburg- EppendorfHamburgGermany
Hong Kong Children's HospitalKowloonHong Kong
IRCCS Istituto G.Gaslini, U.O.GenoaItaly
UOC Neurologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoMilanItaly
UOC Neuropsichiatria Infantile, Area Salute del Bambino, Fondazione Policlinico Universitario A. Gamelli IRCCSRomaItaly
Kobe University HospitalKobeJapan
National Center for Child Health and DevelopmentTokyoJapan
Tokyo Women's Medical University Hospital - PediatricsTokyoJapan
National Center of Neurology and PsychiatryTokyoJapan
Hospital Universitari i Politécnico La FeValenciaComunidad ValenciaSpain
Hospital Sant Joan de DéuBarcelonaSpain
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung CityTaiwan
National Taiwan University HospitalTaipeiTaiwan
Oxford University Hospitals NHS Foundation TrustHeadingtonOxfordUnited Kingdom
Great Ormond Street Hospital for Children NHS Foundation TrustLondonUnited Kingdom
The Newcastle Upon Tyne NHS Hospital NHS Foundation Trust, Royal Victoria InfirmaryNewcastle upon TyneUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

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