Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT07039916
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The Sponsor will also be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 231}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in MG-ADL Score for Antibody-positive Participants', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1', 'timeFrame': 'Week 12'}, {'measure': 'Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score', 'timeFrame': 'Baseline to Week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IMVT-1402', 'Generalized Myasthenia Gravis', 'Acetylcholine receptor', 'Muscle-specific kinase', 'Autoantibody', 'Lipoprotein receptor-related protein 4', 'Autoimmune disease', 'Neonatal fragment crystallizable receptor (FcRn)'], 'conditions': ['Generalized Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit\n* Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.\n* Have had a thymectomy performed \\< 6 months prior to the Screening Visit or have a planned thymectomy during the study\n* Have any active or untreated malignant thymoma\n\nAdditional exclusion criteria are defined in the protocol.'}, 'identificationModule': {'nctId': 'NCT07039916', 'briefTitle': 'Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunovant Sciences GmbH'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'IMVT-1402-3101'}, 'secondaryIdInfos': [{'id': '2024-515979-35-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: IMVT-1402 Dose 1', 'interventionNames': ['Drug: IMVT-1402']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: IMVT-1402 Dose 2', 'interventionNames': ['Drug: IMVT-1402']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/ IMVT-1402', 'interventionNames': ['Drug: Placebo', 'Drug: IMVT-1402']}], 'interventions': [{'name': 'IMVT-1402', 'type': 'DRUG', 'description': '• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)', 'armGroupLabels': ['Group 1: IMVT-1402 Dose 1']}, {'name': 'IMVT-1402', 'type': 'DRUG', 'description': '* Dose 2 SC QW for 12 weeks (Period 1)\n* Dose 2 SC QW for 14 weeks (Period 2)\n* Dose 2 SC QW for 52 weeks (Period 3)', 'armGroupLabels': ['Group 2: IMVT-1402 Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '• Placebo SC QW for 12 weeks (Period 1)', 'armGroupLabels': ['Placebo/ IMVT-1402']}, {'name': 'IMVT-1402', 'type': 'DRUG', 'description': '* Dose 1 SC QW for 14 weeks (Period 2)\n* Dose 1 SC QW for 52 weeks (Period 3)', 'armGroupLabels': ['Group 1: IMVT-1402 Dose 1', 'Placebo/ IMVT-1402']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85028', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1017', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1025', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1042', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1010', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1028', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1023', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1029', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1004', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1027', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1001', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United 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Number - 1014', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40356', 'city': 'Nicholasville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1032', 'geoPoint': {'lat': 37.88063, 'lon': -84.573}}, {'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1005', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '07512', 'city': 'Totowa', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1019', 'geoPoint': {'lat': 40.9051, 'lon': -74.20987}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1034', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1020', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1013', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1044', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '73099', 'city': 'Yukon', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1011', 'geoPoint': {'lat': 35.50672, 'lon': -97.76254}}, {'zip': '97477', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1031', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1030', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29486', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1015', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1021', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75206', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1003', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76208', 'city': 'Denton', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1047', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}, {'zip': '79414', 'city': 'Lubbock', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1048', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Site Number - 1009', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Central Study Contact', 'role': 'CONTACT', 'email': 'clinicaltrials@immunovant.com', 'phone': '18007970414'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunovant Sciences GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}