ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT05881408

Public ClinicalTrials.gov record NCT05881408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 20, 2026, 7:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Study identification

NCT ID
NCT05881408
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sarepta Therapeutics, Inc.
Industry
Enrollment
148 participants

Conditions and interventions

Interventions

  • delandistrogene moxeparvovec Genetic
  • placebo Genetic

Genetic

Eligibility (public fields only)

Age range
Not listed
Sex
Male
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 30, 2023
Primary completion
May 30, 2027
Completion
Jun 29, 2028
Last update posted
Jun 21, 2025

2023 – 2028

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202
Lucile Packard Children's Hospital Stanford Palo Alto California 94304
University of California at Davis Medical Center Sacramento California 95817
Rady Children's Hospital-San Diego San Diego California 92123
University of Florida, UF Health Center for Pediatric Neuromuscular and Rare Diseases Gainesville Florida 32608
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611
The Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center, Pediatric Clinical Research Unit Baltimore Maryland 21287
Boston Children's Hospital Boston Massachusetts 02115
Washington University of St. Louis, St. Louis Children's Hospital St Louis Missouri 63110
University of Rochester, Department of Neurology Rochester New York 14642
Lenox Baker Children's Hospital (Duke University) Durham North Carolina 27705
Nationwide Children's Hospital Columbus Ohio 43205
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Children's Hospital of the King's Daughters Norfolk Virginia 23510

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05881408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 21, 2025 · Synced Apr 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05881408 live on ClinicalTrials.gov.

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