Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 11:51 AM
Study NCT ID:
NCT02057159
Status:
UNKNOWN
Last Update Posted:
2020-03-11
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of NeuroVax™, a 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2023-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2014-02-04', 'studyFirstSubmitQcDate': '2014-02-05', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS', 'timeFrame': 'up to 48 weeks'}], 'secondaryOutcomes': [{'measure': 'Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.', 'timeFrame': '48 Weeks', 'description': 'Secondary MRI measurements'}, {'measure': 'Analyses of clinical relapses', 'timeFrame': '48 Weeks', 'description': 'Analyses of clinical relapses'}, {'measure': 'Measures of neurologic disability EDSS score', 'timeFrame': '48 Weeks', 'description': 'Measures of neurologic disability EDSS score'}, {'measure': 'Immunologic evaluations', 'timeFrame': '48 Weeks', 'description': 'Immunologic evaluations'}, {'measure': 'Safety Evaluation', 'timeFrame': '48 Weeks', 'description': 'Safety Evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Secondary Progress Multiple Sclerosis', 'SPMS', 'Multiple Sclerosis', 'NeuroVax'], 'conditions': ['Secondary Progress Multiple Sclerosis', '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. 200 subjects with Secondary Progressive SPMS", 'detailedDescription': "Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.\n\nStudy Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.\n\nSubject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score \\>= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A\n\n,1 0 0 per arm ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is between 18 and 50 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\n * Creatinine 1 . 5 x high normal.\n * Hemoglobin'}, 'identificationModule': {'nctId': 'NCT02057159', 'briefTitle': 'A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immune Response BioPharma, Inc.'}, 'officialTitle': 'A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'IR902-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NeuroVax', 'description': 'NeuroVax', 'interventionNames': ['Biological: NeuroVax']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IFA Placebo', 'description': 'IFA Placebo', 'interventionNames': ['Biological: IFA Placebo']}], 'interventions': [{'name': 'NeuroVax', 'type': 'BIOLOGICAL', 'description': 'TCR peptides in IFA', 'armGroupLabels': ['NeuroVax']}, {'name': 'IFA Placebo', 'type': 'BIOLOGICAL', 'description': 'IFA Placebo', 'armGroupLabels': ['IFA Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92129', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', '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'}], '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'}}}}