RecruitingPhase 2

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

Canada48 participantsStarted 2025-12-23

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Safety and tolerability as assessed by number of participants with Adverse Events (AEs)

Timeframe: Baseline through Week 108

Trial details

NCT IDNCT07220603

SponsorPepGen Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

PepGen Patient Advocacy

781-797-0979 clinicaltrials@pepgen.com

View on ClinicalTrials.gov More Myotonic Dystrophy 1 trials