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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",[31,43,51,59,67,75,83,88,96,104,112,120],{"facility":32,"status":33,"city":34,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":19},"Mg0033 20040","RECRUITING","Beijing","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},{"facility":44,"status":33,"city":45,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":46,"geoPoint":50,"contacts":19},"Mg0033 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20204","Suzhou",{"type":38,"coordinates":108},[109,110],120.59538,31.30408,{"lat":110,"lon":109},{"facility":113,"status":33,"city":114,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":115,"geoPoint":119,"contacts":19},"Mg0033 20180","Wuhan",{"type":38,"coordinates":116},[117,118],114.26667,30.58333,{"lat":118,"lon":117},{"facility":121,"status":33,"city":122,"state":19,"zip":19,"country":35,"countryCode":36,"cosmosGeoPoint":19,"geoPoint":19,"contacts":19},"Mg0033 20349","Xuzhou SHI",{"type":124,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100611898","phase-4-phase-4-study-evaluating-efficacy-and-safety-of-rozanolixizumab-in-adult-chinese-participants-with-generalized-myasthenia-gravis-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":135,"type":136},40,"ESTIMATED","INTERVENTIONAL",[139],"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.",[142],"Myasthenia Gravis",[144],"Rozanolixizumabg, gMG","2026-05-21",{"date":147,"type":148},"2026-05-22","ACTUAL",{"date":150,"type":148},"2025-12-01",{"date":152,"type":136},"2027-10-15",{"name":154,"class":6},"UCB Biopharma SRL",12]