Trials / Recruiting
RecruitingNCT04626674
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
An Open-Label, Systemic Gene Delivery Study Using Commercial Process Material to Evaluate the Safety of and Expression From SRP-9001 in Subjects With Duchenne Muscular Dystrophy (ENDEAVOR)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- Sponsor
- Sarepta Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label gene transfer therapy study evaluating the safety of and expression from delandistrogene moxeparvovec in participants with DMD. The maximum participant duration for this study is 156 weeks.
Detailed description
Enrollment for Cohorts 1 through 7 has been completed. Cohort 8 is currently enrolling new participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | delandistrogene moxeparvovec | Single IV infusion of delandistrogene moxeparvovec |
Timeline
- Start date
- 2020-11-23
- Primary completion
- 2027-12-31
- Completion
- 2028-02-29
- First posted
- 2020-11-12
- Last updated
- 2026-04-06
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04626674. Inclusion in this directory is not an endorsement.