NCT07220603 An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
| NCT ID | NCT07220603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PepGen Inc |
| Condition | Myotonic Dystrophy 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-12-23 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07220603 clinical trial?
This trial is open to participants of all sexes, studying Myotonic Dystrophy 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07220603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07220603 currently recruiting?
Yes, NCT07220603 is actively recruiting participants. Contact the research team at clinicaltrials@pepgen.com for enrollment information.
Where is the NCT07220603 trial being conducted?
This trial is being conducted at Calgary, Canada, Ottawa, Canada, Saguenay, Canada.
Who is sponsoring the NCT07220603 clinical trial?
NCT07220603 is sponsored by PepGen Inc. The trial plans to enroll 48 participants.