Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT07220603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009223', 'term': 'Myotonic Dystrophy'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020967', 'term': 'Myotonic Disorders'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2025-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by number of participants with Adverse Events (AEs)', 'timeFrame': 'Baseline through Week 108'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DM1', 'Myotonic Dystrophy 1', 'Myotonic Dystrophy', 'PepGen', 'PGN-EDODM1', 'Myotonic Muscular Dystrophy', "Steinhert's Disease", 'Myotonic Dystrophies', 'Genetic Diseases, Inborn', 'Neuromuscular Diseases', 'Nervous System Diseases', 'Musculoskeletal Diseases', 'Myotonic Disorders', 'Muscular Disorders, Atrophic', 'Heredodegenerative Disorders, Nervous System', 'Muscular Diseases'], 'conditions': ['Myotonic Dystrophy 1']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has completed a prior study with PGN-EDODM1\n\nExclusion Criteria:\n\n* Abnormal laboratory tests at screening considered clinically significant by the Investigator\n* 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'}, 'identificationModule': {'nctId': 'NCT07220603', 'briefTitle': 'An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepGen Inc'}, 'officialTitle': 'An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)', 'orgStudyIdInfo': {'id': 'PGN-EDODM1-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PGN-EDODM1', 'interventionNames': ['Drug: PGN-EDODM1']}], 'interventions': [{'name': 'PGN-EDODM1', 'type': 'DRUG', 'description': 'Administered by intravenous (IV) infusion', 'armGroupLabels': ['PGN-EDODM1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'PepGen Patient Advocacy', 'role': 'CONTACT', 'email': 'clinicaltrials@pepgen.com', 'phone': '781-797-0979'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepGen Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}