[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609669":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":192,"collaborators":37,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":196,"sex":202,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":37,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":37,"overallStatus":51,"whyStopped":37,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Nipocalimab","EXPERIMENTAL","Participants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12.",[13],"Drug: Nipocalimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Efgartigimod","ACTIVE_COMPARATOR","Participants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12.",[19],"Drug: Efgartigimod",{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3: Treatment Switch (Nipocalimab)","Participants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12.",[13],[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Nipocalimab","Nipocalimab will be administered intravenously.",[9,21],[31,32],"JNJ-80202135","JNJ-86507083",{"type":26,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Efgartigimod","Efgartigimod will be administered intravenously.",[15],null,[39],{"name":40,"affiliation":5,"role":41},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":37,"email":47},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[49,63,72,82,92,102,112,122,132,142,151,161,172,181],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":37},"Neurology Center of North Orange County","RECRUITING","Fullerton","California","92835","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.92534,33.87029,{"lat":61,"lon":60},{"facility":64,"status":51,"city":65,"state":53,"zip":66,"country":55,"countryCode":56,"cosmosGeoPoint":67,"geoPoint":71,"contacts":37},"The Neurology Group","Pomona","91767",{"type":58,"coordinates":68},[69,70],-117.75228,34.05529,{"lat":70,"lon":69},{"facility":73,"status":51,"city":74,"state":75,"zip":76,"country":55,"countryCode":56,"cosmosGeoPoint":77,"geoPoint":81,"contacts":37},"Advanced Neurology of Colorado","Fort Collins","Colorado","80528",{"type":58,"coordinates":78},[79,80],-105.08442,40.58526,{"lat":80,"lon":79},{"facility":83,"status":51,"city":84,"state":85,"zip":86,"country":55,"countryCode":56,"cosmosGeoPoint":87,"geoPoint":91,"contacts":37},"University of Connecticut","Farmington","Connecticut","06030",{"type":58,"coordinates":88},[89,90],-72.83204,41.71982,{"lat":90,"lon":89},{"facility":93,"status":51,"city":94,"state":95,"zip":96,"country":55,"countryCode":56,"cosmosGeoPoint":97,"geoPoint":101,"contacts":37},"SFM Clinical Research LLC","Boca Raton","Florida","33487",{"type":58,"coordinates":98},[99,100],-80.0831,26.35869,{"lat":100,"lon":99},{"facility":103,"status":51,"city":104,"state":105,"zip":106,"country":55,"countryCode":56,"cosmosGeoPoint":107,"geoPoint":111,"contacts":37},"HSHS St. Elizabeth's Hospital","O'Fallon","Illinois","62269",{"type":58,"coordinates":108},[109,110],-89.91121,38.59227,{"lat":110,"lon":109},{"facility":113,"status":51,"city":114,"state":115,"zip":116,"country":55,"countryCode":56,"cosmosGeoPoint":117,"geoPoint":121,"contacts":37},"Josephson Wallack Munshower Neurology, PC","Indianapolis","Indiana","46256",{"type":58,"coordinates":118},[119,120],-86.15804,39.76838,{"lat":120,"lon":119},{"facility":123,"status":51,"city":124,"state":125,"zip":126,"country":55,"countryCode":56,"cosmosGeoPoint":127,"geoPoint":131,"contacts":37},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":58,"coordinates":128},[129,130],-83.04575,42.33143,{"lat":130,"lon":129},{"facility":133,"status":51,"city":134,"state":135,"zip":136,"country":55,"countryCode":56,"cosmosGeoPoint":137,"geoPoint":141,"contacts":37},"Velocity Clinical Research, Inc.","Raleigh","North Carolina","27607 6010",{"type":58,"coordinates":138},[139,140],-78.63861,35.7721,{"lat":140,"lon":139},{"facility":143,"status":51,"city":144,"state":135,"zip":145,"country":55,"countryCode":56,"cosmosGeoPoint":146,"geoPoint":150,"contacts":37},"Atrium Health Wake Forest Baptist","Winston-Salem","27157",{"type":58,"coordinates":147},[148,149],-80.24422,36.09986,{"lat":149,"lon":148},{"facility":152,"status":51,"city":153,"state":154,"zip":155,"country":55,"countryCode":56,"cosmosGeoPoint":156,"geoPoint":160,"contacts":37},"Texas Neurology","Dallas","Texas","75206",{"type":58,"coordinates":157},[158,159],-96.80667,32.78306,{"lat":159,"lon":158},{"facility":162,"status":51,"city":163,"state":37,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":37},"Rambam Medical Center","Haifa","3109601","Israel","IL",{"type":58,"coordinates":168},[169,170],34.99928,32.81303,{"lat":170,"lon":169},{"facility":173,"status":51,"city":174,"state":37,"zip":175,"country":165,"countryCode":166,"cosmosGeoPoint":176,"geoPoint":180,"contacts":37},"Sourasky Medical Center","Tel Aviv","6423906",{"type":58,"coordinates":177},[178,179],34.78057,32.08088,{"lat":179,"lon":178},{"facility":182,"status":51,"city":183,"state":37,"zip":184,"country":185,"countryCode":186,"cosmosGeoPoint":187,"geoPoint":191,"contacts":37},"HOCH Health Ostschweiz Kantonsspital St.Gallen","Sankt Gallen","9007","Switzerland","CH",{"type":58,"coordinates":188},[189,190],9.37477,47.42391,{"lat":190,"lon":189},{"type":193,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100609669","phase-3-comparative-efficacy-of-nipocalimab-and-efgartigimod-in-participants-with-generalized-myasthenia-gravis-100609669",false,"NCT07217587","Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis","Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab","EPIC","Inclusion criteria:\n\nFor all arms:\n\n* Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening\n* Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a\u002Fb, III a\u002Fb, or IV a\u002Fb at screening and positive for acetylcholine receptor (AChR) antibodies\n* Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (\\>=) 5 with less than (\\\u003C) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits\n\nCriteria specific to Arms 1 and 2 only:\n\n\\- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and\u002For immunosuppressants\u002Fimmunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy\n\nCriteria specific to Arm 3:\n\n\\- Treatment with efgartigimod IV or subcutaneous (SC) for \\>=1 cycle, and the final cycle is consistent with product information\n\nExclusion criteria:\n\n* Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his\u002Fher gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study\n* Currently has a malignancy or has a history of malignancy within 3 years before baseline\n\nCriteria specific to Arms 1 and 2 only:\n\n\\- Has received treatment for MG with an FcRn-targeting therapy\n\nCriteria specific to Arm 3 only:\n\n\\- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod","ALL","18 Years","74 Years",{"count":206,"type":207},115,"ESTIMATED","INTERVENTIONAL",[210],"PHASE3","The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).",[213],"Myasthenia Gravis","2026-06-04",{"date":216,"type":217},"2026-06-05","ACTUAL",{"date":219,"type":217},"2026-01-05",{"date":221,"type":207},"2029-07-31",{"name":5,"class":6},14]