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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) — ENVISION  

Duchenne Muscular Dystrophy Clinical Trial

Official title:
A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of SRP- 9001 in Non-Ambulatory and Ambulatory Subjects With Duchenne Muscular Dystrophy (ENVISION)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05881408
Study type Interventional
Source Sarepta Therapeutics, Inc.
Contact Sarepta Therapeutics Inc., For Clinical Trial Information, Selec
Phone 1-888-SAREPTA (1-888-727-3782)
Email SareptAlly@sarepta.com
Status Recruiting
Phase Phase 3
Start date May 31, 2023
Completion date January 31, 2027
View Details
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