Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT07284420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events and serious adverse events in parts A and B', 'timeFrame': 'Up to 21 weeks'}], 'secondaryOutcomes': [{'measure': 'MG-ADL total score change from baseline at week 18 in part B (cycle 2 day 29) compared with MG ADL total score change from baseline at week 4 in part A', 'timeFrame': 'Up to 18 weeks', 'description': 'The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)'}, {'measure': 'Proportion of participants reaching MSE at any point in part B cycles 1 and 2, and part B cycles 1 or 2', 'timeFrame': 'Up to 21 weeks', 'description': 'MSE: Minimal symptom expression'}, {'measure': 'MG-ADL total score changes from baseline over time in part B compared with part A', 'timeFrame': 'Up to 21 weeks', 'description': 'The Myasthenia Gravis Activities of Daily Living (MG- ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)'}, {'measure': 'QMG total score change from baseline at week 18 in part B (cycle 2 day 29) compared with QMG total score change from baseline at week 4 in part A', 'timeFrame': 'Up to 18 weeks', 'description': 'The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)'}, {'measure': 'QMG total score changes from baseline over time in part B compared with part A', 'timeFrame': 'Up to 21 weeks', 'description': 'The Quantitative myasthenia gravis (QMG) includes 13 items that measure endurance or fatigability and accounts for fluctuations in disease state. The total score ranges from 0 (no disease severity) to 39 (highest disease severity)'}, {'measure': 'Proportion of participants who have a 50% MG ADL total score improvement in part B cycles 1 and 2', 'timeFrame': 'Up to 21 weeks', 'description': 'The Myasthenia Gravis Activities of Daily Living (MG ADL) scale is an 8-item instrument used to assess MG symptoms and their effects on daily activities. The total score ranges from 0 (normal symptoms) to 24 (most severe symptoms)'}, {'measure': 'Proportion of participants who have positive PASS in part B cycles 1 and 2, and part B cycles 1 or 2', 'timeFrame': 'Up to 21 weeks', 'description': 'PASS: Patient acceptable symptom state'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AChR-Ab Seropositive Generalized Myasthenia Gravis', 'Myasthenia Gravis', 'MG', 'gMG', 'Generalized Myasthenia Gravis', 'Generalized Myasthenia Gravis (gMG)']}, 'descriptionModule': {'briefSummary': "This study is part of the ADAPT Forward platform study. ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.\n\nThe aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.", 'detailedDescription': 'Once the master protocol and ISA1 screening periods are completed, eligible participants can enroll in the run-in period (part A) where they will receive efgartigimod IV. Eligible participants can then continue to the add-on period (part B) where they will receive both efgartigimod IV and empasiprubart IV.\n\nParticipants who are not eligible for part B will continue directly to the safety follow-up period (part C) where they will receive efgartigimod IV only.\n\nThe study duration for each participant is approximately up to 54 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)\n* Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb\n* Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration\n\nExclusion Criteria:\n\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Any known complement deficiency\n* Current administration of a complement inhibitor or received zilucoplan or eculizumab \\<2 months or ravulizumab \\<6 months before the first study drug administration\n* Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)'}, 'identificationModule': {'nctId': 'NCT07284420', 'briefTitle': 'ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod', 'organization': {'class': 'INDUSTRY', 'fullName': 'argenx'}, 'officialTitle': 'An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod', 'orgStudyIdInfo': {'id': 'ARGX-999-2-MG-20001'}, 'secondaryIdInfos': [{'id': '2025-522492-28-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efgartigimod IV + Empasiprubart IV', 'description': 'Participants receive efgartigimod IV in part A, B and C and empasiprubart IV in part B', 'interventionNames': ['Biological: Efgartigimod IV', 'Biological: Empasiprubart IV']}, {'type': 'EXPERIMENTAL', 'label': 'Efgartigimod IV (part A + C)', 'description': 'Participants not eligible for part B, receiving efgartigimod IV in part A and C', 'interventionNames': ['Biological: Efgartigimod IV']}], 'interventions': [{'name': 'Efgartigimod IV', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of efgartigimod', 'armGroupLabels': ['Efgartigimod IV (part A + C)', 'Efgartigimod IV + Empasiprubart IV']}, {'name': 'Empasiprubart IV', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of empasiprubart', 'armGroupLabels': ['Efgartigimod IV + Empasiprubart IV']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sabine Coppieters, MD', 'role': 'CONTACT', 'email': 'clinicaltrials@argenx.com', 'phone': '857-350-4834'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'argenx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}