Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02149706
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2014-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508473', 'term': 'NeuroVax vaccine'}, {'id': 'C098825', 'term': "HIV-1 immunogen, incomplete Freund's adjuvant"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2014-05-24', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score', 'timeFrame': '48 Weeks', 'description': 'The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements'}], 'secondaryOutcomes': [{'measure': 'Secondary measurements objectives immunologic evaluations', 'timeFrame': '48 Weeks', 'description': 'Secondary measurements objectives immunologic evaluations increases in white blood cell counts \\& FOXP+3 expression increases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary Progress Multiple Sclerosis', 'SPMS', 'Multiple Sclerosis', 'NeuroVax'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.", 'detailedDescription': 'The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages Eligible for Study: 18 Years to 70 Years\n* Genders Eligible for Study: Both\n* Accepts Healthy Volunteers: No Criteria\n* Subject is between 18 and 70 years of age, inclusive.\n* Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.\n* Expanded Disability Status Scale (EDSS) \\>=score 3.5 (Appendix B).\n* Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .\n* Laboratory values within the following limits:\n* Creatinine 1 . 5 x high normal.\n* Hemoglobin\n\nExclusion Criteria:\n\n* Subjects currently prescribed Campath or Lemtrada'}, 'identificationModule': {'nctId': 'NCT02149706', 'briefTitle': 'A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immune Response BioPharma, Inc.'}, 'officialTitle': 'A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination', 'orgStudyIdInfo': {'id': 'Immune Response 2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeuroVax', 'description': 'NeuroVax', 'interventionNames': ['Biological: NeuroVax']}, {'type': 'PLACEBO_COMPARATOR', 'label': "IFA Incomplete Freund's Adjuvant", 'description': "Incomplete Freund's Adjuvant IFA", 'interventionNames': ["Biological: IFA Incomplete Freund's Adjuvant"]}], 'interventions': [{'name': 'NeuroVax', 'type': 'BIOLOGICAL', 'description': 'NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA', 'armGroupLabels': ['NeuroVax']}, {'name': "IFA Incomplete Freund's Adjuvant", 'type': 'BIOLOGICAL', 'description': "IFA Placebo Incomplete Freund's Adjuvant", 'armGroupLabels': ["IFA Incomplete Freund's Adjuvant"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '92129', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Richard M Bartholomew, PhD', 'role': 'CONTACT', 'email': 'Richardmbartholomew@gmail.com', 'phone': '858-414-4664'}, {'name': 'Richard Bartholomew, Phd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CRO', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Richard M Bartholomew, Ph.D', 'role': 'CONTACT', 'email': 'Richardmbartholomew@gmail.com', 'phone': '1-858-414-4664'}, {'name': 'Richard Bartholomew', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Richard M Bartholomew, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Immune Response BioPharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immune Response BioPharma, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'cro', 'class': 'AMBIG'}], 'responsibleParty': {'type': 'SPONSOR'}}}}