Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-30 @ 12:31 AM
Study NCT ID:
NCT05752032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-15
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delayed adverse events', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Knee pain', 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of change from baseline in knee pain as measured using a Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable)'}, {'measure': 'Knee function', 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of change from baseline in knee function as measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) function in daily living subscale ranging from 0 (extreme problems) to 100 (no problems)'}, {'measure': 'Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)', 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of change from baseline in MOAKS, focusing on bone marrow lesions, articular cartilage, and effusion-synovitis, where higher scores reflect worse disease'}, {'measure': 'Joint space width', 'timeFrame': 'Up to 3 years', 'description': 'Evaluation of change from baseline in joint space width in mm as measured on knee radiograph'}, {'measure': 'Incidence of total knee replacement', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adeno-associated virus', 'Gene therapy', 'ICM-203', 'Osteoarthritis'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'This is an observational study of the long term safety and efficacy of ICM-203.', 'detailedDescription': 'Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who received ICM-203 or matching placebo in clinical studies', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous receipt of ICM-203 or matching placebo\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05752032', 'briefTitle': 'A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'ICM Co. Ltd.'}, 'officialTitle': 'A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo', 'orgStudyIdInfo': {'id': 'ICM 20-1002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ICM-203', 'description': 'Participants who previously received ICM-203 in ICM-203 clinical studies', 'interventionNames': ['Genetic: ICM-203']}, {'label': 'Placebo', 'description': 'Participants who previously received placebo in ICM-203 clinical studies', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ICM-203', 'type': 'GENETIC', 'description': 'Long term follow-up', 'armGroupLabels': ['ICM-203']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Long term follow-up', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Barwon Health', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}], 'overallOfficials': [{'name': 'Alison Heald, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ICM Co. Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ICM Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}