Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05776069
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014842', 'term': 'von Willebrand Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-08', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]', 'timeFrame': 'From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively', 'description': 'Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentrations of single IV and SC doses of VGA039', 'timeFrame': 'From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively'}, {'measure': 'Pharmacodynamics of single IV and SC doses of VGA039', 'timeFrame': 'From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively'}, {'measure': 'Incidence of Anti-drug antibodies to VGA039', 'timeFrame': 'From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Von Willebrand Disorder', 'VWD', 'Star Therapeutics', 'Vega Therapeutics', 'VIVID', 'VIVID-1', 'VIVID-2', 'VIVID-3', 'VIVID-5', 'Bleeding disorders', 'VGA039', 'Blood coagulation disorders'], 'conditions': ['Von Willebrand Diseases']}, 'descriptionModule': {'briefSummary': 'The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.', 'detailedDescription': 'This first-in-human study consists of 5 parts based on the subject population. Part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to 8 cohorts in healthy volunteers. Part 2 is an open-label, SAD of SC or IV VGA039 in up to 8 cohorts in subjects diagnosed with VWD. All participants will be enrolled, treated, and followed up for 15 weeks (IV SAD) or 8 weeks(SC SAD). Part 3 is an open-label, Phase 1b study of SC multiple doses (MD) of VGA039 in up to 4 cohorts. Part 4 is an open-label, Phase 2 study of SC single, surgical prophylaxis (SP) doses of VGA039 administered prior to a minor surgical procedure in subjects diagnosed with VWD in up to 2 cohorts. Part 5 is an open-label extension (OLE) study of SC MD of VGA039 in eligible subjects diagnosed with VWD who have previously participated in a VGA039 interventional trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria (All Subjects)\n\n* Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2\n* Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5\n* No clinically significant laboratory, ECG, or vital signs results.\n\nAdditional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2\n\nAdditional Key Inclusion Criteria (for Subjects in Part 2 Only)\n\n* Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.\n* Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.\n\nExclusion Key Criteria (All Subjects)\n\n* Use of hormonal contraceptives within 56 days prior to administration of the study drug.\n* Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.\n* Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.\n* History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.\n* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.\n\nAdditional Key Exclusion Criterion (Subjects in Part 1 Only)\n\n• Baseline FVIII activity \\> 150 IU/dL.\n\nAdditional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)\n\n* Baseline FVIII activity \\> 50 IU/dL.\n* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.'}, 'identificationModule': {'nctId': 'NCT05776069', 'briefTitle': 'Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vega Therapeutics, Inc'}, 'officialTitle': 'A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)', 'orgStudyIdInfo': {'id': 'VGA039-CP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1', 'description': 'Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined', 'interventionNames': ['Drug: VGA039', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Cohorts A-H IV or SC VGA039 dose to be determined', 'interventionNames': ['Drug: VGA039']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3', 'description': 'Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined', 'interventionNames': ['Drug: VGA039']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4', 'description': 'Cohorts of VGA039 single dose for surgical prophylaxis', 'interventionNames': ['Drug: VGA039']}, {'type': 'EXPERIMENTAL', 'label': 'Part 5', 'description': 'Multiple doses of VGA039 in open label extension'}], 'interventions': [{'name': 'VGA039', 'type': 'DRUG', 'description': 'Single doses of VGA039', 'armGroupLabels': ['Part 1', 'Part 2', 'Part 4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Single doses of Placebo', 'armGroupLabels': ['Part 1']}, {'name': 'VGA039', 'type': 'DRUG', 'description': 'Multiple doses of VGA039', 'armGroupLabels': ['Part 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90007', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orthopedic Institute for Children (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Science 37 Recruitment Team', 'role': 'CONTACT', 'email': 'recruitment@science37.com', 'phone': '984-377-3737'}], 'facility': 'Science 37, Inc.', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hemophilia Center of Western PA', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington Center for Bleeding Disorders', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53233', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Versiti Comprehensive Center for Bleeding Disorders', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queenland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Vienna', 'state': 'Vienna', 'status': 'COMPLETED', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '20211-030', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '13083-878', 'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hemocentro Unicamp', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - USP Endereco', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Hamilton Health Sciences Corporation', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Queens University', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'St. Michaels Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '400022', 'city': 'Sion', 'state': 'Mumbai', 'status': 'RECRUITING', 'country': 'India', 'facility': 'K J Somaiya Super Speciality Hospital & Research Centre', 'geoPoint': {'lat': 25.37394, 'lon': 83.07157}}, {'city': 'Johannesburg', 'status': 'RECRUITING', 'country': 'South Africa', 'facility': 'Charlotte Maxeke Johannesburg Academic Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'Edgbaston', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'SO16 6YD.', 'city': 'Southampton', 'state': 'Hampshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E12ES', 'city': 'Whitechapel', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal London Hospital, Clinical Haematology Research', 'geoPoint': {'lat': 51.51382, 'lon': -0.06583}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Clinical Trials', 'role': 'CONTACT', 'email': 'medinfo@star-therapeutics.com', 'phone': '650-466-8041'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vega Therapeutics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}