Clinical Trial

A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)

Study acronym: ENVISION
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The study will evaluate the safety and efficacy of delandistrogene moxeparvovec gene transfer therapy in non-ambulatory and ambulatory males with DMD. This is a randomized, double-blind, placebo-controlled 2-part study. Participants will be in the study for approximately 128 weeks. All participants will have the opportunity to receive intravenous (IV) delandistrogene moxeparvovec in either Part 1 or Part 2.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2023-05-19; most recent amendment 2026-05-21.
Status change: Recruiting → Active, Not Recruiting 2025-06-18
Status change: Not Yet Recruiting → Recruiting 2023-06-30
Trial Details
NCT Number NCT05881408
Lead Sponsor Sarepta Therapeutics, Inc.
Collaborators: Hoffmann-La Roche
Conditions Duchenne Muscular Dystrophy
Enrollment 148 participants
Start Date 2023-05-31
Primary Completion 2027-05-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-22