[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611898":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":122,"collaborators":19,"id":124,"slug":19,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":19,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":19,"enrollmentInfo":132,"targetDuration":19,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},{"fullName":5,"class":6},"UCB Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rozanolixizumab","EXPERIMENTAL","Participants will receive 6 dose per cycle of subcutaneous infusion of rozanolixizumab",[13],"Drug: Rozanolixizumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Subcutaneous infusion",[9],null,[21],{"name":22,"affiliation":23,"role":24},"UCB Cares","001 844 599 22733 (UCB)","STUDY_DIRECTOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+18445992273","ucbcares@ucb.com",[31,42,50,58,66,74,82,87,95,103,111,119],{"facility":32,"status":33,"city":34,"state":19,"zip":19,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":19},"Mg0033 20040","RECRUITING","Beijing","China",{"type":37,"coordinates":38},"Point",[39,40],116.39723,39.9075,{"lat":40,"lon":39},{"facility":43,"status":33,"city":44,"state":19,"zip":19,"country":35,"cosmosGeoPoint":45,"geoPoint":49,"contacts":19},"Mg0033 20261","Changchun",{"type":37,"coordinates":46},[47,48],125.32278,43.88,{"lat":48,"lon":47},{"facility":51,"status":33,"city":52,"state":19,"zip":19,"country":35,"cosmosGeoPoint":53,"geoPoint":57,"contacts":19},"Mg0033 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20347",{"type":37,"coordinates":85},[79,80],{"lat":80,"lon":79},{"facility":88,"status":33,"city":89,"state":19,"zip":19,"country":35,"cosmosGeoPoint":90,"geoPoint":94,"contacts":19},"Mg0033 20172","Shanghai",{"type":37,"coordinates":91},[92,93],121.45806,31.22222,{"lat":93,"lon":92},{"facility":96,"status":33,"city":97,"state":19,"zip":19,"country":35,"cosmosGeoPoint":98,"geoPoint":102,"contacts":19},"Mg0033 20184","Shenzhen",{"type":37,"coordinates":99},[100,101],114.0683,22.54554,{"lat":101,"lon":100},{"facility":104,"status":33,"city":105,"state":19,"zip":19,"country":35,"cosmosGeoPoint":106,"geoPoint":110,"contacts":19},"Mg0033 20204","Suzhou",{"type":37,"coordinates":107},[108,109],120.59538,31.30408,{"lat":109,"lon":108},{"facility":112,"status":33,"city":113,"state":19,"zip":19,"country":35,"cosmosGeoPoint":114,"geoPoint":118,"contacts":19},"Mg0033 20180","Wuhan",{"type":37,"coordinates":115},[116,117],114.26667,30.58333,{"lat":117,"lon":116},{"facility":120,"status":33,"city":121,"state":19,"zip":19,"country":35,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Mg0033 20349","Xuzhou SHI",{"type":123,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100611898",false,"NCT07246564","Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","An Open-label, Prospective, Single-arm Study Assessing the Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* Study participant must be ≥18 years of age at the time of signing the informed consent form (ICF)\n* Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at the Screening Visit based on study participant's history and supported by previous evaluation\n* Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) documented in the medical history at the Screening Visit\n* Study participant has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening Visit.\n* Study participant with a myasthenia gravis-activities of daily living (MG-ADL) score of at least 3 points from non-ocular symptoms and a quantitative myasthenia gravis (QMG) score of at least 11 at the Screening and Baseline visits in the first Treatment Cycle.\n* Study participant is considered for additional treatment by the investigator\n* Body weight ≥35kg at the Screening Visit\n\nExclusion Criteria:\n\n* Study participant has a known hypersensitivity to any components of the study drug or any other anti-neonatal Fc receptor (anti-FcRn) medications\n* Study participant has a clinically important active infection including unresolved or not adequately treated infection in the opinion of the investigator\n* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current\u002Fhistory of nontuberculous mycobacterial infection (NTMBI)\n* Study participant has previously received rozanolixizumab drug product\n* Study participant has received any vaccine in the 4 weeks prior to the initiation of rozanolixizumab treatment or intends to receive any vaccine within 2 weeks after the last infusion of rozanolixizumab. Note: For participants that are on rozanolixizumab treatment, vaccination with live or live-attenuated vaccines is not recommended. During the whole study period, all other vaccines should take place at least 2 weeks after the last infusion of a Treatment Cycle and 4 weeks before initiating the next cycle\n* Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within the timeframe shorter than the treatment-free period\n* Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis. Note: Impending Crisis is defined as bulbar or respiratory symptoms of a patient who significantly worsens in a short time (≤2 weeks) and meet MGFA IVb or score 3 in one QMG bulbar muscle item, or score 2 in respiratory muscle item, or bulbar+respiratory items score ≥4","ALL","18 Years",{"count":133,"type":134},40,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.",[140],"Myasthenia Gravis",[142],"Rozanolixizumabg, gMG","2026-05-21",{"date":145,"type":146},"2026-05-22","ACTUAL",{"date":148,"type":146},"2025-12-01",{"date":150,"type":134},"2027-10-15",{"name":152,"class":6},"UCB Biopharma SRL",12]