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NCT06128564 · ClinicalTrials.gov record · last posted 2026-08-10

A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD)

Name: A Gene Delivery Study to Evaluate the Safety and Expression of Delandistrogene Moxeparvovec in Participants Under the Age of Four With Duchenne Muscular Dystrophy (DMD) — clinical trial record (NCT06128564)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: ENVOL

StatusActive, Not Recruiting

PhasePhase 2

SponsorHoffmann-La Roche

Started2023-11-29

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

This open-label, single-arm study will evaluate the safety and expression of delandistrogene moxeparvovec in participants with DMD. Participants will be in the study for approximately 264 weeks.

Protocol amendment history 2 changes detected by DataLookout

2026-05-12

Primary completion moved earlier: 2030-02-28 → 2026-03-04

2026-05-12

Completion moved earlier: 2034-01-30 → 2030-02-18

Trial Details

NCT Number	NCT06128564
Lead Sponsor	Hoffmann-La Roche Collaborators: Sarepta Therapeutics, Inc.
Conditions	Duchenne Muscular Dystrophy
Enrollment	13 participants
Start Date	2023-11-29
Primary Completion	2026-03-04 (estimated)
Study Completion	2030-02-18 (estimated)
Updated on ClinicalTrials.gov	2026-08-10