[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611898":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":42,"interventions":49,"overallOfficials":54,"centralContacts":59,"locations":64,"responsibleParty":158,"collaborators":35,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":35,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":35,"enrollmentInfo":169,"targetDuration":35,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":178,"overallStatus":67,"whyStopped":35,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},{"fullName":5,"class":6},"UCB Pharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score in the first Treatment Cycle","The total MG-ADL score is obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with a higher score indicating more disability.\n\nA positive change indicates worsening and a negative change indicates improvement.","Baseline to Day 43 (in first treatment cycle)",[14,17,20,23,26,29,33],{"measure":15,"description":16,"timeFrame":12},"MG-ADL responder (≥2.0-point improvement from Baseline) at Day 43 in the first Treatment Cycle","A MG-ADL responder is defined as achieving at least 2.0-point improvement in the MG-ADL total score from Baseline.",{"measure":18,"description":19,"timeFrame":12},"Change from Baseline to Day 43 in Myasthenia Gravis-Composite (MG-C) score within first 6 week treatment cycle","The MG-C scale is a validated assessment, with a higher score indicating more severe disease and a 3-point change being of clinical relevance. The scale tests 10 items, with individual items being weighted differently. The overall score ranges from 0 to 50 (more severe disease).\n\nThe items included ptosis\u002Fupward gaze (range: 0 \\[\\>45 second\\] - 3 \\[Immediate\\]), double vision on lateral gaze (range: 0 \\[\\>45 second\\] - 4 \\[Immediate\\]), eye closure (range: 0 \\[Normal\\] - 2 \\[severe weakness\\]), talking (range: 0 \\[Normal\\] - 6 \\[difficult to understand speech\\]), chewing (range: 0 \\[Normal\\] - 6 \\[gastric tube\\]), swallowing (range: 0 \\[Normal\\] - 6 \\[gastric tube\\]), breathing (range: 0 \\[Normal\\] - 9 \\[ventilator dependence\\]), neck flexion (range: 0 \\[Normal\\] - 4 \\[severe weakness\\]), shoulder abduction (range: 0 \\[Normal\\] - 5 \\[severe weakness\\]) and hip flexion (range: 0 \\[Normal\\] - 5 \\[severe weakness\\]), lower scores= lower disease activity.",{"measure":21,"description":22,"timeFrame":12},"Change from Baseline to Day 43 in Quantitative Myasthenia Gravis (QMG) score within first 6-week treatment cycle","The total QMG score is obtained by summing the responses to each individual item (13 items \\[ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity\\]; Responses: None=0, Mild=1, Moderate=2, Severe=3). The QMG is a validated assessment, with a higher score indicating more severe disease. Scoring for each item ranges from no weakness (0) to severe weakness (3), with an overall score range from 0 to 39. A 3-point change in the total score is considered clinically relevant.",{"measure":24,"description":25,"timeFrame":12},"Change from Baseline to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' score within first 6-week treatment cycle","The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose response option that best describes how frequently they experienced muscle weakness fatigability (items 34-42) over the past 7 days using a 5-point Likert scale (1=\"none of the time\" to 5=\"all of the time\") for each item.",{"measure":27,"description":28,"timeFrame":12},"Change from Baseline to Day 43 in MG Symptoms PRO 'Physical Fatigue' score within first 6-week treatment cycle","The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Study participants will be asked to choose the response option that best describes how frequently they experienced physical fatigue (items 19-33) over the past 7 days using a 5-point Likert scale (1=\"none of the time\" to 5=\"all of the time\") for each item.",{"measure":30,"description":31,"timeFrame":32},"Percentage of participants with treatment-emergent adverse events (TEAEs)","Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.","Up to End of study (40 weeks)",{"measure":34,"description":31,"timeFrame":32},"Percentage of participants with TEAEs leading to withdrawal of investigational medicinal product (IMP)",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"NA","SINGLE_GROUP","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Rozanolixizumab","EXPERIMENTAL","Participants will receive 6 dose per cycle of subcutaneous infusion of rozanolixizumab",[48],"Drug: Rozanolixizumab",[50],{"type":51,"name":44,"description":52,"armGroupLabels":53,"otherNames":35},"DRUG","Subcutaneous infusion",[44],[55],{"name":56,"affiliation":57,"role":58},"UCB Cares","001 844 599 22733 (UCB)","STUDY_DIRECTOR",[60],{"name":56,"role":61,"phone":62,"phoneExt":35,"email":63},"CONTACT","+18445992273","ucbcares@ucb.com",[65,77,85,93,101,109,117,122,130,138,146,155],{"facility":66,"status":67,"city":68,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":35},"Mg0033 20040","RECRUITING","Beijing","China","CN",{"type":72,"coordinates":73},"Point",[74,75],116.39723,39.9075,{"lat":75,"lon":74},{"facility":78,"status":67,"city":79,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":80,"geoPoint":84,"contacts":35},"Mg0033 20261","Changchun",{"type":72,"coordinates":81},[82,83],125.32278,43.88,{"lat":83,"lon":82},{"facility":86,"status":67,"city":87,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":88,"geoPoint":92,"contacts":35},"Mg0033 20295","Changsha",{"type":72,"coordinates":89},[90,91],112.97087,28.19874,{"lat":91,"lon":90},{"facility":94,"status":67,"city":95,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":96,"geoPoint":100,"contacts":35},"Mg0033 20348","Fuzhou",{"type":72,"coordinates":97},[98,99],119.30611,26.06139,{"lat":99,"lon":98},{"facility":102,"status":67,"city":103,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":104,"geoPoint":108,"contacts":35},"Mg0033 20269","Guangzhou",{"type":72,"coordinates":105},[106,107],113.25,23.11667,{"lat":107,"lon":106},{"facility":110,"status":67,"city":111,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":35},"Mg0033 20185","Jinan",{"type":72,"coordinates":113},[114,115],116.99722,36.66833,{"lat":115,"lon":114},{"facility":118,"status":67,"city":111,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":119,"geoPoint":121,"contacts":35},"Mg0033 20347",{"type":72,"coordinates":120},[114,115],{"lat":115,"lon":114},{"facility":123,"status":67,"city":124,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":125,"geoPoint":129,"contacts":35},"Mg0033 20172","Shanghai",{"type":72,"coordinates":126},[127,128],121.45806,31.22222,{"lat":128,"lon":127},{"facility":131,"status":67,"city":132,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":133,"geoPoint":137,"contacts":35},"Mg0033 20184","Shenzhen",{"type":72,"coordinates":134},[135,136],114.0683,22.54554,{"lat":136,"lon":135},{"facility":139,"status":67,"city":140,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":141,"geoPoint":145,"contacts":35},"Mg0033 20204","Suzhou",{"type":72,"coordinates":142},[143,144],120.59538,31.30408,{"lat":144,"lon":143},{"facility":147,"status":148,"city":149,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":150,"geoPoint":154,"contacts":35},"Mg0033 20180","ACTIVE_NOT_RECRUITING","Wuhan",{"type":72,"coordinates":151},[152,153],114.26667,30.58333,{"lat":153,"lon":152},{"facility":156,"status":67,"city":157,"state":35,"zip":35,"country":69,"countryCode":70,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Mg0033 20349","Xuzhou SHI",{"type":159,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"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":170,"type":171},40,"ESTIMATED","INTERVENTIONAL",[174],"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.",[177],"Myasthenia Gravis",[179],"Rozanolixizumabg, gMG","2026-09-10",{"date":182,"type":183},"2026-09-11","ACTUAL",{"date":185,"type":183},"2025-12-01",{"date":187,"type":171},"2027-10-15",{"name":189,"class":6},"UCB Biopharma SRL",12]