Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT04980495
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2021-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2024-02-20', 'completionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-27', 'dispFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of the average MG-ADL total score change from baseline during the visit of week 1 through week 21 by regimen arm', 'timeFrame': 'Up to 21 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}], 'secondaryOutcomes': [{'measure': 'Incidence of AEs, SAEs and AESIs', 'timeFrame': 'Up to 136 weeks', 'description': 'AE : adverse event; SAE: serious adverse event; AESI: adverse event of special interest'}, {'measure': 'Change from baseline in the MG-ADL total score over time', 'timeFrame': 'Up to 126 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}, {'measure': 'Normalized area under the effect curve (AUEC) of MG-ADL total score improvement from baseline', 'timeFrame': 'Up to 21 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}, {'measure': 'Characterization of MG-ADL total score change from baseline', 'timeFrame': 'Up to 21 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}, {'measure': 'Percentage of participants who have a ≥ 2, 3, 4, or 5 points improvement in MG-ADL total score from baseline', 'timeFrame': 'Up to 21 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}, {'measure': 'Percentage of time participants have a change in MG-ADL total score of at least 2 points from baseline during Week 4 through Week 21', 'timeFrame': 'Up to 21 weeks', 'description': 'The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}, {'measure': 'Percentage of participants who achieve MSE, defined as a MG-ADL total score of 0 or 1', 'timeFrame': 'Up to 21 weeks', 'description': 'MSE = minimal symptom expression; The MG-ADL (Myasthenia Gravis Activities of Daily Living) scale assesses MG symptoms and their effects on daily activities. The total score varies between 0 and 24, with higher total scores indicating more impairment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Generalized Myasthenia Gravis', 'MG - Myasthenia Gravis', 'gMG']}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG).\n\nParticipants will receive efgartigimod throughout the study. The participants will be randomized to the continuous regimen arm or to the cyclic regimen arm. The study consists of a part A (regimen comparison period) where participants will continue the treatment based on the treatment regimen arm they were assigned at randomization. Following part A, participants will enter part B (extension period) where all participants will receive efgartigimod in the continuous regimen. The study duration for participants is up to 138 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age, at the time of signing the informed consent.\n* Diagnosed with Generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by a physical exam and confirmed seropositivity for anti-acetylcholine receptor antibodies (AChR-Abs).\n* Meets the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, or IV\n\nExclusion Criteria:\n\n* Any other condition that, in the opinion of the investigator, would interfere with an accurate assessment of the clinical symptoms of gMG and/or put the participant at undue risk\n* A thymectomy within 3 months of screening\n* Use of the following prior or concomitant therapies:\n\n 1. intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) within 14 days of day 1\n 2. Rituximab within 6 months of day 1\n 3. Eculizumab within 1 month of day 1\n 4. Other monoclonal antibodies (eg, adalimumab, tocilizumab, ixekizumab)'}, 'identificationModule': {'nctId': 'NCT04980495', 'acronym': 'ADAPT NXT', 'briefTitle': 'An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'ARGX-113-2003'}, 'secondaryIdInfos': [{'id': '2024-510932-36-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efgartigimod IV - continuous regimen', 'description': 'Participants receiving efgartigimod IV on a continuous regimen', 'interventionNames': ['Biological: Efgartigimod IV']}, {'type': 'EXPERIMENTAL', 'label': 'Efgartigimod IV - cyclic regimen', 'description': 'Participants receiving efgartigimod IV on a cyclic regimen', 'interventionNames': ['Biological: Efgartigimod IV']}], 'interventions': [{'name': 'Efgartigimod IV', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusions of efgartigimod', 'armGroupLabels': ['Efgartigimod IV - continuous regimen', 'Efgartigimod IV - cyclic regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 10 - US0010007', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Investigator Site 7 - US0010001', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 9 - 0010006', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site 15 - US0010014', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '30910', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site 16 - US0010009', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 8 - US0010003', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60008', 'city': 'Meadows', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site 6 - US0010008', 'geoPoint': {'lat': 40.74448, 'lon': -88.80479}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site 12 - US0010004', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Investigator Site 13 - US0010013', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site 17 - US0010012', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site 11 - US0010011', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator Site 14 - US0010010', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Investigator Site 26 - AT0430002', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigator Site 27 - AT0430001', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigator Site 28 - BE0320001', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'N6A 5A5', 'city': 'London', 'country': 'Canada', 'facility': 'Investigator Site 29 - CA0019003', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H3A 2B4', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigator site 37 - CA0019002', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '33604', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Investigator Site 23 - FR0330005', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Investigator Site 24 - FR0330004', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Investigator Site 20 - FR0330001', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06001', 'city': 'Nice', 'country': 'France', 'facility': 'Investigator Site 25 - FR0330003', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Investigator site 38 - FR0330002', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 2 - GEO9950002', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0114', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 1 - GEO9950001', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0114', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Investigator Site 3 - GEO9950003', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigator Site 33 - DE0490004', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Investigator Site 36 - DE0490002', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Investigator Site 32 - DE0490001', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Investigator Site 34 - DE0490005', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '40139', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Investigator Site 31 - IT0390005', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Investigator Site 30 - IT0390004', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Investigator Site 21 - IT0390002', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Investigator site 39 - IT0390006', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Investigator Site 22 - IT0390001', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '1105', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Investigator Site 35 - NL0310001', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '31-426', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Investigator Site 5 - PL0480002', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-093', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Investigator Site 4 - PL0480001', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Investigator Site 18 - ES0340002', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Investigator Site 19 - ES0340001', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}