At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 126 enrolled
Drug / intervention
delandistrogene moxeparvovec +1 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating delandistrogene moxeparvovec and placebo for Duchenne Muscular Dystrophy. Completed, enrolled 126 participants across 42 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesBelgium, Germany, Hong Kong, Italy, Japan, Spain, Taiwan, United Kingdom, United States
CollaboratorsHoffmann-La Roche
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionOct 2023
Study CompletionOct 2024
TodayJul 2026
First PostedOct 27, 2021
Enrollment StartOct 27, 2021
Primary CompletionOct 4, 2023
Study CompletionOct 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.7 years ago
Interventions
delandistrogene moxeparvovecgenetic
Single IV infusion of delandistrogene moxeparvovec.
placebogenetic
Single IV infusion of matching placebo.