Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-29 @ 9:36 AM
Study NCT ID:
NCT06834035
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004820', 'term': 'Epidermolysis Bullosa'}, {'id': 'D016107', 'term': 'Epidermolysis Bullosa Acquisita'}, {'id': 'D016108', 'term': 'Epidermolysis Bullosa Dystrophica'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007074', 'term': 'Immunoglobulin G'}], 'ancestors': [{'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events and Effects', 'timeFrame': '9 Months', 'description': 'Occurrence of adverse events and effects'}, {'measure': 'Percent Change in Wound Area', 'timeFrame': '9 Months', 'description': 'The wound area at the end of the treatment phase compared to the wound area at the beginning of the treatment phase.\n\nWound healing (% and cm\\^2) over the course of the treatment phase compared to the wound healing (% and cm\\^2), over the observation phase.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidermolysis Bullosa', 'Epidermolysis Bullosa Acquisita', 'Dystrophic Epidermolysis Bullosa', 'Recessive Dystrophic Epidermolysis Bullosa', 'Collagen 7', 'C7', 'Col7', 'EB', 'EBA', 'DEB', 'RDEB', 'Antibodies', 'Collagen VII', 'IV IgG', 'IgG', 'IVIgG', 'C7 Antibodies', 'Collagen 7 Antibodies', 'Collagen VII Antibodies', 'Vyjuvek', 'B-VEC'], 'conditions': ['Epidermolysis Bullosa', 'Epidermolysis Bullosa Acquisita', 'Dystrophic Epidermolysis Bullosa', 'Recessive Dystrophic Epidermolysis Bullosa']}, 'descriptionModule': {'briefSummary': 'The study objective is to see if IV IgG treatment in Recessive Dystrophic Epidermolysis Bullosa (RDEB) skin in conjunction with VYJUVEK treatment improves wound healing and affects the levels of C7 and HSV-1 antibody levels in serum.\n\nFewer wounds, more rapidly healing wounds, and decreased C7 and HSV-1 antibodies could improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of generalized Recessive dystrophic epidermolysis bullosa (RDEB) demonstrated by COL7A1 mutations.\n2. Diagnosis of EBA demonstrated by the presence of levels of serum C7 antibodies above the normal ELISA range\n3. Baseline skin blistering greater than 5% total body surface area\n4. 1 wound at least 20 cm\\^2 able to be entirely treated with Vyjuvek weekly\n5. 1 wound at least 20 cm\\^2 that has never been treated with Vyjuvek\n6. Ongoing VYJUVEK treatment.\n\nExclusion Criteria:\n\n1. History of thrombotic event(s)\n2. History of cardiac failure\n3. History of renal failure\n4. IgA deficiency'}, 'identificationModule': {'nctId': 'NCT06834035', 'acronym': 'IV IgG', 'briefTitle': 'Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Targeting Collagen VII Antibodies With IV IgG in Dystrophic Epidermolysis Bullosa', 'orgStudyIdInfo': {'id': '73958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intra-Personal Control', 'description': 'There is one arm of the study. First, each participant undergoes a 3-month observational period, during which they continue application of their prescribed Vyjuvek. After 3 months, they enter the treatment period, during which they continue their Vyjuvek application and, in addition, receive the IV IgG treatment.', 'interventionNames': ['Biological: Immunoglobulin G']}], 'interventions': [{'name': 'Immunoglobulin G', 'type': 'BIOLOGICAL', 'otherNames': ['IgG', 'IV IgG'], 'description': 'Purified IgG from human serum, delivered via IV', 'armGroupLabels': ['Intra-Personal Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94163', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'cimino@stanford.edu', 'phone': '650-723-3439'}, {'name': 'Matt P Marinkovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}], 'centralContacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'cimino@stanford.edu', 'phone': '650-723-3439'}, {'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'kunju@stanford.edu', 'phone': '6507214902'}], 'overallOfficials': [{'name': 'Matt P Marinkovich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M. Peter Marinkovich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Epidermolysis Bullosa Research Partnership', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Dermatology', 'investigatorFullName': 'M. Peter Marinkovich', 'investigatorAffiliation': 'Stanford University'}}}}