Long-Term Study of PGN-EDODM1 Safety in People With Myotonic Dystrophy Type 1 Who Completed a Previous PGN-EDODM1 Study

What this Trial Is About

This research aims to learn about the long-term safety and tolerability of PGN-EDODM1 in people with myotonic dystrophy type 1 DM1 who have previously participated in a study involving PGN-EDODM1. The study is a phase 2 open-label extension designed to gather more information on how participants respond to ongoing treatment with this drug. Participants will receive PGN-EDODM1 through intravenous IV infusion once every 4 weeks. This dosing schedule continues for up to 108 weeks, allowing researchers to monitor the effects of the medication over a long period. The study does not include a placebo group and is not blinded, meaning both participants and researchers know the treatment being given. During the study, participants will be closely monitored for any adverse events and other safety concerns. Evaluations will include tracking side effects and tolerability from the start of the study through week 108. Researchers will also assess how the drug behaves in the body over time. Participants may undergo laboratory tests and other assessments to support these evaluations, with a focus on maintaining participant safety throughout the study period.

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