NCT05967351

A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Sarepta Therapeutics, Inc. · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. No study drug will be administered as part of this study.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
GENETIC	delandistrogene moxeparvovec	No study drug will be administered as part of this study. Eligible participants who received treatment with delandistrogene moxeparvovec during a previous clinical study will be included.

Timeline

• Start date: 2023-09-27
• Primary completion: 2033-10-31
• Completion: 2033-10-31
• First posted: 2023-08-01
• Last updated: 2026-02-06

Locations

38 sites across 9 countries: United States, Belgium, Germany, Hong Kong, Italy, Japan, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study