Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-04 @ 2:02 PM
Study NCT ID:
NCT05049161
Status:
TERMINATED
Last Update Posted:
2022-07-07
First Post:
2021-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Extension of Study GNC-401
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-17', 'releaseDate': '2024-04-29'}, {'resetDate': '2024-11-20', 'releaseDate': '2024-09-25'}], 'estimatedResultsFirstSubmitDate': '2024-04-29'}}, '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': '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': 33}}, 'statusModule': {'whyStopped': 'Drug product unavailability', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-04', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and tolerability:adverse event', 'timeFrame': '48 weeks', 'description': 'Number of Patients With Treatment-Related Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Neuroimaging', 'timeFrame': '48 weeks', 'description': 'Change in Brain parenchymal volume fraction at Week 48 compared to Baseline'}, {'measure': 'Neuroimaging', 'timeFrame': '48 weeks', 'description': 'change in magnetization transfer Saturation (MTSat) in periventricular NAWM at at Week 48 compared to Baseline'}, {'measure': 'Neuroimaging', 'timeFrame': '48 weeks', 'description': 'Change in thalamic volume fraction at Week 48 compared to Baseline'}, {'measure': 'Neuroimaging', 'timeFrame': '48 weeks', 'description': 'Change in magnetization Transfer Saturation (MTSat) in cortex at Week 48 compared to Baseline'}, {'measure': 'Neuroimaging', 'timeFrame': '48 weeks', 'description': 'Change in T1 and T2 lesion volume at Week 48 compared to Baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsing Forms of Multiple Sclerosis', 'GNbAC1', 'Human Endogenous Retrovirus Type W', 'HERV-W', 'Temelimab'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This Phase II study is a monocenter, long-term extension study of study GNC-401 and will start after individual completion of Week 48 of the GNC-401 study. At entry, all patients will receive active treatment with temelimab. The patients of the placebo group in study GNC-401 will be re-randomized to temelimab 18 mg/kg, 36 mg/kg or 54 mg/kg (1:1:1), while the patients who received temelimab in study GNC-401 will continue with the same dose in study GNC-402. Following final analysis of the results of the GNC-401 study, the Sponsor may switch all patients to an optimal dose of temelimab based on safety and efficacy demonstrated in the GNC-401 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n1. The patient has given written informed consent to participate in the study;\n2. Current diagnosis of RMS, based on the McDonald 2017 criteria ;\n3. Patients must have completed study GNC-401. Completion is defined as having performed the Week 48 assessments of study GNC 401;\n4. Have no clinical (relapses) or MRI signs (≥2 new T2 lesions of \\>10 mm diameter) of acute MS disease activity, based on the Week 48 MRI of study GNC 401, or, if yes, been retreated prior to study entry with rituximab;\n5. Have a B cell count ≤0.05 x 109 CD19 cells/L (assessed at the end of study GNC 401, or before inclusion in this study GNC 402 (available result from routine clinical practice); if not retreated with rituximab before entering study GNC-402, monthly B-cell count will be executed and retreatment will be considered by the treating physician when B-cells are \\>0.05 x 109 CD19 cells/L);\n\nMain exclusion criteria\n\n1. The emergence of any disease diagnosis during the course of study GNC-401 that is not due to MS and could better explain the patient's neurological signs and symptoms;\n2. Body weight ≤40 kg;\n3. Contraindication to continue rituximab therapy;\n4. Has received rituximab less than 12 days prior to study entry;\n5. Use of any of the following medications since Week 48 of the GNC 401 study:\n\n 1. Interferon (IFN) β, glatiramer acetate, IV immunoglobulin (IVIG), dimethyl fumarate or teriflunomide;\n 2. Natalizumab, mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation;\n 3. Highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine;\n 4. Any experimental drugs for the treatment of MS;\n6. Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater lymphopenia (based on Week 48 of study GNC 401);\n7. Any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study, including:\n\n 1. Diagnosis or history of schizophrenia;\n 2. Current diagnosis of moderate to severe bipolar disorder, major depressive disorder, major depressive episode, history of suicide attempt, or current suicidal ideation;\n 3. Current or past (within the last 2 years) alcohol or drug abuse;\n8. History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (New York Heart Association \\[NYHA\\] class 3 or 4);\n9. Known inability to undergo an MRI scan;\n10. Contraindications to the use of 5% glucose solution for infusion;\n11. Inability to follow study instructions, or complete study assessments, as defined by the protocol;\n12. Any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the Investigator;\n13. Pregnant or breastfeeding women;\n14. Abnormal liver function tests: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2 times upper limit of normal range (ULN), or conjugated bilirubin \\>2 times ULN, or alkaline phosphatase (AP) or gamma-glutamyl transferase (GGT) \\>3 times ULN;"}, 'identificationModule': {'nctId': 'NCT05049161', 'briefTitle': 'A Long-term Extension of Study GNC-401', 'organization': {'class': 'INDUSTRY', 'fullName': 'GeNeuro SA'}, 'officialTitle': 'A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab', 'orgStudyIdInfo': {'id': 'GNC-402'}, 'secondaryIdInfos': [{'id': '2021-001973-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temelimab 18 mg/kg', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: Temelimab 18 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Temelimab 36 mg/kg', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: Temelimab 36mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Temelimab 54 mg/kg', 'description': 'Monthly IV repeated dose', 'interventionNames': ['Drug: Temelimab 54 mg/kg']}], 'interventions': [{'name': 'Temelimab 18 mg/kg', 'type': 'DRUG', 'description': 'temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)', 'armGroupLabels': ['Temelimab 18 mg/kg']}, {'name': 'Temelimab 36mg/kg', 'type': 'DRUG', 'description': 'temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)', 'armGroupLabels': ['Temelimab 36 mg/kg']}, {'name': 'Temelimab 54 mg/kg', 'type': 'DRUG', 'description': 'temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)', 'armGroupLabels': ['Temelimab 54 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113 65', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Center for Neurology, Academic Specialist Center', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'David Leppert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GeNeuro Innovation SAS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GeNeuro Innovation SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-29', 'type': 'RELEASE'}, {'date': '2024-09-17', 'type': 'RESET'}, {'date': '2024-09-25', 'type': 'RELEASE'}, {'date': '2024-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'GeNeuro Innovation SAS'}}}}