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ACTIVE NOT RECRUITING Phase 3

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)

NCT05881408 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • GENETIC delandistrogene moxeparvovec
  • GENETIC placebo

Study Locations (20)

California

  • Lucile Packard Children's Hospital Stanford — Palo Alto
  • University of California at Davis Medical Center — Sacramento
  • Rady Children's Hospital-San Diego — San Diego

Arkansas

  • Arkansas Children's Hospital — Little Rock

Florida

  • University of Florida, UF Health Center for Pediatric Neuromuscular and Rare Diseases — Gainesville

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago

Maryland

  • The Johns Hopkins Hospital, Charlotte R. Bloomberg Children's Center, Pediatric Clinical Research Unit — Baltimore

Massachusetts

  • Boston Children's Hospital — Boston

Missouri

  • Washington University of St. Louis, St. Louis Children's Hospital — St Louis

New York

  • University of Rochester, Department of Neurology — Rochester

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2023-05-31
Est. Completion 2028-06-30
Phase Phase 3

Sponsor

Sarepta Therapeutics

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05881408

The ClinicalTrials.gov registry entry for NCT05881408 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarepta Therapeutics, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions — of which delandistrogene moxeparvovec is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05881408 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Arkansas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05881408 about?

NCT05881408 is a clinical study titled "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)". 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 ...

What is the current status of trial NCT05881408?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2023-05-31. Estimated completion is 2028-06-30.

What conditions does trial NCT05881408 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05881408?

The interventions under investigation include: delandistrogene moxeparvovec (GENETIC), placebo (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05881408?

This trial is sponsored by Sarepta Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05881408 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial