Status:
NOT_YET_RECRUITING
An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Lead Sponsor:
PepGen Inc
Conditions:
Myotonic Dystrophy 1
Eligibility:
All Genders
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Participant has completed a prior study with PGN-EDODM1
Exclusion
- Abnormal laboratory tests at screening considered clinically significant by the Investigator
- Use of an investigational drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-lives of the study drug (whichever is longer) prior to study entry
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07220603
Start Date
October 1 2025
End Date
October 1 2029
Last Update
October 24 2025
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