Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02782858
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
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': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-19', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-05-23', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative number of Gd-enhancing T1 lesions in brain MRI', 'timeFrame': 'Week 12 to 24'}]}, 'oversightModule': {'oversightHasDmc': True}, '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 (MS).\n\nThis study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* For male or female with reproductive potential, use of reliable means of contraception;\n* RRMS according to the 2010 revised McDonald criteria;\n* Disease activity characterised by at least one documented relapse within the last 12 months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within the last 3 months;\n* EDSS score \\< 6.0.\n\nMain Exclusion Criteria:\n\n* Patients suffering from Secondary Progressive MS and Primary Progressive MS at screening;\n* Pregnant and nursing women.'}, 'identificationModule': {'nctId': 'NCT02782858', 'acronym': 'CHANGE-MS', 'briefTitle': 'Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeNeuro SA'}, 'officialTitle': 'An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'GNC-003'}, 'secondaryIdInfos': [{'id': '2015-004059-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 GNbAC1', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: GNbAC1']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 GNbAC1', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: GNbAC1']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 GNbAC1', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: GNbAC1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GNbAC1', 'type': 'DRUG', 'description': 'Monthly IV repeated dose', 'armGroupLabels': ['Dose 1 GNbAC1', 'Dose 2 GNbAC1', 'Dose 3 GNbAC1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Monthly IV repeated dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Zagreb', 'country': 'Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Jihlava', 'country': 'Czechia', 'geoPoint': {'lat': 49.3961, 'lon': 15.59124}}, {'city': 'Tallinn', 'country': 'Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeNeuro SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Les Laboratoires Servier (LLS)', 'class': 'UNKNOWN'}, {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}, {'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}