An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
NCT07220603 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-03-30
Summary
The purpose of this study is to learn about the long-term safety and tolerability of PGN-EDODM1 in participants with myotonic dystrophy type 1 (DM1) who have completed a prior study with PGN-EDODM1.
Conditions
- Myotonic Dystrophy 1
Interventions
- DRUG
-
PGN-EDODM1
Administered by intravenous (IV) infusion
Sponsors & Collaborators
-
PepGen Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-23
- Primary Completion
- 2029-01-31
- Completion
- 2029-01-31
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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