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NCT05096221 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Duchenne Muscular Dystrophy, sponsored by Sarepta Therapeutics.

Completed
Registry status
Phase 3
Development phase
126
Enrollment target
20
Study locations

NCT05096221 is a Phase 3 study of Duchenne Muscular Dystrophy that has completed, run by Sarepta Therapeutics. The registered enrollment target is 126 participants, below the 410-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05096221, a Phase 3 study of Duchenne Muscular Dystrophy, has completed, sponsored by Sarepta Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
126 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Duchenne Muscular Dystrophy

Interventions

  • GENETIC delandistrogene moxeparvovec
  • GENETIC placebo

Study Locations (20)

California

  • UC San Diego Altman Clinical and Translational Research Institute - La Jolla
  • UCLA Medical Center - Los Angeles
  • Lucile Packard Children's Hospital at Stanford - Palo Alto
  • University of California, Davis - Sacramento

New York

  • Columbia University/NYPH - New York
  • University of Rochester - Rochester

Arkansas

  • Arkansas Children's - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • University of Florida - Gainesville

Illinois

  • Lurie Children's Hospital of Chicago - Chicago

Iowa

  • University of Iowa Stead Family Children's Hospital - Iowa City

Maryland

  • The Johns Hopkins Hospital - Baltimore

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2021-10-27
Est. Completion 2024-10-25
Phase Phase 3

Sponsor

Sarepta Therapeutics

33 total trials

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What the Registry Record Tells You About NCT05096221

The ClinicalTrials.gov registry entry for NCT05096221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 410-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (69% lower). The listed sponsor is Sarepta Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.

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.

NCT05096221 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, New York, Arkansas.

Frequently Asked Questions

What is clinical trial NCT05096221 about?

NCT05096221 is a clinical study titled "A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)". 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 seco...

What is the current status of trial NCT05096221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2021-10-27. Estimated completion is 2024-10-25.

What conditions does trial NCT05096221 study?

This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.

What interventions are being tested in trial NCT05096221?

The interventions under investigation include: delandistrogene moxeparvovec (GENETIC), placebo (GENETIC).

Who is sponsoring clinical trial NCT05096221?

This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05096221 being conducted?

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

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.