Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-29 @ 12:01 PM
Study NCT ID:
NCT07155668
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open label study with no masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of the three study arms.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Emergent Adverse Event (TEAE) incidence rate', 'timeFrame': 'Through Week 24', 'description': 'Treatment Emergent Adverse Event (TEAE) incidence rate'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic outcome measures', 'timeFrame': 'Through Week 24', 'description': 'Time of maximum serum concentration (Tmax) of VRDN-003'}, {'measure': 'Pharmacokinetic outcome measures', 'timeFrame': 'Through Week 24', 'description': 'Maximum serum concentration (Cmax) of VRDN-003'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Thyroid Eye Disease']}, 'descriptionModule': {'briefSummary': 'This is a clinical trial assessing the safety, tolerability and pharmacokinetics (PK) of an investigational drug, VRDN-003, in participants with TED (Thyroid Eye Disease)', 'detailedDescription': 'This is a randomized (meaning participants will be assigned to study arms by chance), open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to), parallel-group study that will enroll participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable and to see how the body reacts to VRDN-003 when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED either via autoinjector or via vial and syringe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a clinical diagnosis of TED with or without proptosis, with any CAS (0-7) and in the opinion of the Investigator may benefit from VRDN-003\n* Not require immediate ophthalmological or orbital surgery in the study eye for any reason\n* Must agree to use highly effective contraception as specified in the protocol\n* Female TED participants must have a negative serum pregnancy test at screening\n\nKey Exclusion Criteria:\n\n* Must not have received prior treatment with another anti-IGF-1R therapy\n* Must not have received systemic corticosteroids for any condition, including TED, or selenium within 2 weeks prior to first dose.\n* Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED, within 12 weeks prior to first dose\n* Must not have received an investigational agent/device for any condition, including TED, within 8 weeks or longer (depending on the type of agent/device) prior to first dose\n* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose\n* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit\n* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results\n* Must not have abnormal hearing test before first dose or history of ear conditions considered significant by study doctor\n* Must not have a history of inflammatory bowel disease\n* Female TED participants must not be pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT07155668', 'briefTitle': 'A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viridian Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Open-label Study Evaluating the Safety, Tolerability and Pharmacokinetics of VRDN-003 Administered Subcutaneously in Participants With Thyroid Eye Disease (TED)', 'orgStudyIdInfo': {'id': 'VRDN-003-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VRDN-003 every 4 weeks using autoinjector', 'description': '6 subcutaneous administrations of VRDN-003 \\[1 loading dose of 600mg and 5 doses of 300mg\\]', 'interventionNames': ['Drug: VRDN-003', 'Device: Autoinjector']}, {'type': 'EXPERIMENTAL', 'label': 'VRDN-003 every 8 weeks using autoinjector', 'description': '3 subcutaneous administrations of VRDN-003 \\[1 loading dose of 600mg and 2 doses of 300mg\\]', 'interventionNames': ['Drug: VRDN-003', 'Device: Autoinjector']}, {'type': 'EXPERIMENTAL', 'label': 'VRDN-003 every 8 weeks using vial and syringe', 'description': '3 subcutaneous administrations of VRDN-003 \\[1 loading dose of 600mg and 2 doses of 300mg\\]', 'interventionNames': ['Drug: VRDN-003']}], 'interventions': [{'name': 'VRDN-003', 'type': 'DRUG', 'description': 'VRDN-003 is an investigational, subcutaneously administered, humanized monoclonal antibody directed against the Insulin-like Growth Factor-1 receptor (IGF-1R).', 'armGroupLabels': ['VRDN-003 every 4 weeks using autoinjector', 'VRDN-003 every 8 weeks using autoinjector', 'VRDN-003 every 8 weeks using vial and syringe']}, {'name': 'Autoinjector', 'type': 'DEVICE', 'description': 'The autoinjector is a single-dose, disposable, ready-to-use delivery device', 'armGroupLabels': ['VRDN-003 every 4 weeks using autoinjector', 'VRDN-003 every 8 weeks using autoinjector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '714-375-5970'}], 'facility': 'Marvel Clinical Research', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '310-645-4673'}], 'facility': 'United Medical Research Institute', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '33990', 'city': 'Cape Coral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '239-383-7062'}], 'facility': 'C&A Clinical Trials Corp', 'geoPoint': {'lat': 26.56285, 'lon': -81.94953}}, {'zip': '34744', 'city': 'Kissimmee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '407-807-6506'}], 'facility': 'Ilumina Medical Research', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '786-534-3806'}], 'facility': 'Med-Care Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '855-227-5005'}], 'facility': 'Continental Clinical Research, llc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '305-833-0053'}], 'facility': 'Hype Clinical Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60462', 'city': 'Orland Park', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '937-727-7598'}], 'facility': 'Advanced Quality Medical Research, LLC', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}, {'zip': '02189', 'city': 'East Weymouth', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '617-314-2732'}], 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.21399, 'lon': -70.92032}}, {'zip': '48026', 'city': 'Fraser', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '586-296-7250'}], 'facility': 'Fraser Eye Center', 'geoPoint': {'lat': 42.5392, 'lon': -82.94937}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '734-608-4107'}], 'facility': 'Kahana Oculoplastic and Orbital Surgery', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '89128', 'city': 'Sparks', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '775-877-9777'}], 'facility': 'Vector Clinical Trials', 'geoPoint': {'lat': 39.53491, 'lon': -119.75269}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '713-798-7692'}], 'facility': 'Baylor College of Medicine, Alkek Eye Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '281-723-8593'}], 'facility': 'Neuro Eye Clinical Trials INC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viridian Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}