[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641863":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":110,"collaborators":19,"id":112,"slug":19,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":19,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":19,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":134,"whyStopped":19,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Alexion Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ravulizumab","EXPERIMENTAL","Participants will receive ravulizumab for up to 26 weeks.",[13],"Drug: Ravulizumab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants will receive ravulizumab via intravenous (IV) infusion.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Alexion Pharmaceuticals, Inc. (Sponsor)","CONTACT","1-855-752-2356","clinicaltrials@alexion.com",[27,38,46,54,62,70,78,86,94,102],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Research Site","Beijing","100053","China",{"type":33,"coordinates":34},"Point",[35,36],116.39723,39.9075,{"lat":36,"lon":35},{"facility":28,"status":19,"city":39,"state":19,"zip":40,"country":31,"cosmosGeoPoint":41,"geoPoint":45,"contacts":19},"Changchun","130021",{"type":33,"coordinates":42},[43,44],125.32278,43.88,{"lat":44,"lon":43},{"facility":28,"status":19,"city":47,"state":19,"zip":48,"country":31,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"Fuzhou","350001",{"type":33,"coordinates":50},[51,52],119.30611,26.06139,{"lat":52,"lon":51},{"facility":28,"status":19,"city":55,"state":19,"zip":56,"country":31,"cosmosGeoPoint":57,"geoPoint":61,"contacts":19},"Jinan","250012",{"type":33,"coordinates":58},[59,60],116.99722,36.66833,{"lat":60,"lon":59},{"facility":28,"status":19,"city":63,"state":19,"zip":64,"country":31,"cosmosGeoPoint":65,"geoPoint":69,"contacts":19},"Shanghai","200040",{"type":33,"coordinates":66},[67,68],121.45806,31.22222,{"lat":68,"lon":67},{"facility":28,"status":19,"city":71,"state":19,"zip":72,"country":31,"cosmosGeoPoint":73,"geoPoint":77,"contacts":19},"Shijiazhuang","050000",{"type":33,"coordinates":74},[75,76],114.47861,38.04139,{"lat":76,"lon":75},{"facility":28,"status":19,"city":79,"state":19,"zip":80,"country":31,"cosmosGeoPoint":81,"geoPoint":85,"contacts":19},"Taiyuan","030001",{"type":33,"coordinates":82},[83,84],112.56028,37.86944,{"lat":84,"lon":83},{"facility":28,"status":19,"city":87,"state":19,"zip":88,"country":31,"cosmosGeoPoint":89,"geoPoint":93,"contacts":19},"Tianjin","300050",{"type":33,"coordinates":90},[91,92],117.17667,39.14222,{"lat":92,"lon":91},{"facility":28,"status":19,"city":95,"state":19,"zip":96,"country":31,"cosmosGeoPoint":97,"geoPoint":101,"contacts":19},"Wuhan","430030",{"type":33,"coordinates":98},[99,100],114.26667,30.58333,{"lat":100,"lon":99},{"facility":28,"status":19,"city":103,"state":19,"zip":104,"country":31,"cosmosGeoPoint":105,"geoPoint":109,"contacts":19},"Zhengzhou","450000",{"type":33,"coordinates":106},[107,108],113.64861,34.75778,{"lat":108,"lon":107},{"type":111,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100641863",false,"NCT07596784","Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)","An Open-label, Single-arm, Multi-center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Patients With Generalized Myasthenia Gravis (gMG)","Inclusion (key)\n\n* Confirmed generalized MG: Diagnosis ≥6 months before screening, anti-AChR antibody positive, and supportive diagnostic evidence (e.g., abnormal SFEMG\u002FRNS or response to anticholinesterase therapy).\n* Disease severity: MGFA Class II-IV at screening.\n* Symptoms threshold: MG-ADL ≥6 at screening and on Day 1.\n* Meningococcal vaccination: Up to date within 3 years or vaccinated before first dose to mitigate risk with complement inhibition.\n* Body weight: ≥40 kg.\n* Vaccinated against meningococcal infections within the 3 years prior to, or at the time of, initiating study drug.\n\nExclusion (key)\n\n* Thymic disease:\n\n  * Untreated thymic malignancy\u002Fcarcinoma\u002Fthymoma excluded.\n  * Prior thymic malignancy allowed only if treatment completed \\>5 years, no recurrence in last 5 years, and clear CT\u002FMRI within 6 months.\n  * Prior benign thymoma allowed if confirmed benign, treatment \\>12 months ago, no recurrence in last 12 months, and clear CT\u002FMRI within 6 months; otherwise follow malignancy rules.\n  * Thymectomy within the last 12 months\n* Infection risk:\n\n  * History of meningococcal disease or unresolved infection, or active systemic infection within 14 days of Day 1 excluded.\n  * Persistent\u002Frecurrent infections in past 12 months that add risk\n  * HIV, active HBV (HBsAg+ or anti-HBc+ with anti-HBs-), or active HCV (unless documented successful treatment\u002FSVR)\n* Safety\u002Fmedical status:\n\n  * Hypersensitivity to study drug components (including murine proteins)\n  * Recent hospitalization ≥24 hours within 28 days of screening\n  * Substance use disorder per DSM within 12 months.\n  * Recent\u002Fother malignancy within 5 years (except as above for thymic).\n* Prior\u002FConcomitant Therapy\n\n  * Complement inhibitor within \\\u003C 5 half-lives before Day 1.\n  * Human neonatal Fc receptor (FcRn) inhibitor within \\\u003C 5 half-lives before Day 1.\n  * Rituximab, ocrelizumab or other B cell-depleting therapy within ≤ 6 months (180 days) before Day 1.\n  * Periodic (chronic) administration of PP\u002FPE, or IVIg as maintenance therapy received or scheduled within ≤ 6 months before Day 1\n* Key labs:\n\n  * ALT \\>2× ULN, direct bilirubin \\>2× ULN.\n  * eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or on dialysis.\n  * Any other clinically significant lab abnormality making participation unsafe.\n\nNote: Other protocol-defined criteria may apply and should be verified during full eligibility review.","ALL","18 Years","130 Years",{"count":122,"type":123},20,"ESTIMATED","INTERVENTIONAL",[126],"PHASE3","The primary purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in Chinese adult participants with Acetylcholine receptor (AChR) + Generalized Myasthenia Gravis (gMG).",[129,130],"Generalized Myasthenia Gravis","gMG",[132,130,133],"generalized myasthenia gravis","ravulizumab","NOT_YET_RECRUITING","2026-06-17",{"date":137,"type":138},"2026-06-22","ACTUAL",{"date":140,"type":123},"2026-07-30",{"date":142,"type":123},"2027-08-27",{"name":5,"class":6},10]