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Recruiting Phase 2 NCT07220603

An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)

Trial Parameters

Condition Myotonic Dystrophy 1
Sponsor PepGen Inc
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 48
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2025-12-23
Completion 2029-01
Interventions
PGN-EDODM1

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 Criteria: * Participant has completed a prior study with PGN-EDODM1 Exclusion Criteria: * 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

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