Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-08 @ 4:20 PM
Study NCT ID:
NCT03239860
Status:
TERMINATED
Last Update Posted:
2020-10-20
First Post:
2017-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'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': 'C581064', 'term': 'temelimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'whyStopped': 'Based on R\\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term safety of GNbAC1', 'timeFrame': '96 Weeks', 'description': 'The main parameters evaluated to assess the long term safety will be:\n\nAE and SAE, clinical safety laboratory, IgG4 dosing, vital signs, physical examination, ECGs, Anti-drug antibody and C-SSRS scale'}], 'secondaryOutcomes': [{'measure': 'Long term efficacy of GNbAC1 in terms of MRI outcomes', 'timeFrame': '96 Weeks'}, {'measure': 'Long term efficacy of GNbAC1 in terms of relapse rate', 'timeFrame': '96 Weeks'}, {'measure': 'Long term efficacy of GNbAC1 in terms of disability', 'timeFrame': '96 Weeks'}, {'measure': 'Long term efficacy of GNbAC1 in terms of disease progression', 'timeFrame': '96 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Multiple Sclerosis Relapsing-Remitting', 'GNbAC1', 'MRI', 'Monoclonal antibody', 'Multiple Sclerosis associated retrovirus MSRV', 'MS', 'RRMS', 'HERV-W', 'Temelimab'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '34240656', 'type': 'DERIVED', 'citation': 'Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.\n\nThe study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Patients must have completed Period 2 of study GNC-003 and must meet all eligibility criteria for the GNC-004 study\n* Patients (male or female with reproductive potential) must agree to use highly effective methods of birth control\n* Provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form.\n\nMain Exclusion Criteria:\n\n* Patients not having completed the study GNC-003\n* Pregnancy\n* The emergence of any disease diagnosis during the course of study GNC-003 that is not MS and could better explain the patient's neurological signs and symptoms"}, 'identificationModule': {'nctId': 'NCT03239860', 'acronym': 'ANGEL-MS', 'briefTitle': 'Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeNeuro SA'}, 'officialTitle': 'A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'GNC-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 GNbAC1', 'description': 'Monthly IV', 'interventionNames': ['Drug: GNbAC1 Monoclonal Antibody']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 GNbAC1', 'description': 'Monthly IV', 'interventionNames': ['Drug: GNbAC1 Monoclonal Antibody']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 GNbAC1', 'description': 'Monthly IV', 'interventionNames': ['Drug: GNbAC1 Monoclonal Antibody']}], 'interventions': [{'name': 'GNbAC1 Monoclonal Antibody', 'type': 'DRUG', 'description': 'Monthly IV', 'armGroupLabels': ['Dose 1 GNbAC1', 'Dose 2 GNbAC1', 'Dose 3 GNbAC1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Hospital', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Jihlava', 'country': 'Czechia', 'facility': 'Hospital', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Hospital', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Hospital', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeNeuro SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Les Laboratoires Servier', 'class': 'UNKNOWN'}, {'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}, {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}