[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641863":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":111,"collaborators":19,"id":113,"slug":19,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":19,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":19,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":135,"whyStopped":19,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"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",[27,39,47,55,63,71,79,87,95,103],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":19},"Research Site","Beijing","100053","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},{"facility":28,"status":19,"city":40,"state":19,"zip":41,"country":31,"countryCode":32,"cosmosGeoPoint":42,"geoPoint":46,"contacts":19},"Changchun","130021",{"type":34,"coordinates":43},[44,45],125.32278,43.88,{"lat":45,"lon":44},{"facility":28,"status":19,"city":48,"state":19,"zip":49,"country":31,"countryCode":32,"cosmosGeoPoint":50,"geoPoint":54,"contacts":19},"Fuzhou","350001",{"type":34,"coordinates":51},[52,53],119.30611,26.06139,{"lat":53,"lon":52},{"facility":28,"status":19,"city":56,"state":19,"zip":57,"country":31,"countryCode":32,"cosmosGeoPoint":58,"geoPoint":62,"contacts":19},"Jinan","250012",{"type":34,"coordinates":59},[60,61],116.99722,36.66833,{"lat":61,"lon":60},{"facility":28,"status":19,"city":64,"state":19,"zip":65,"country":31,"countryCode":32,"cosmosGeoPoint":66,"geoPoint":70,"contacts":19},"Shanghai","200040",{"type":34,"coordinates":67},[68,69],121.45806,31.22222,{"lat":69,"lon":68},{"facility":28,"status":19,"city":72,"state":19,"zip":73,"country":31,"countryCode":32,"cosmosGeoPoint":74,"geoPoint":78,"contacts":19},"Shijiazhuang","050000",{"type":34,"coordinates":75},[76,77],114.47861,38.04139,{"lat":77,"lon":76},{"facility":28,"status":19,"city":80,"state":19,"zip":81,"country":31,"countryCode":32,"cosmosGeoPoint":82,"geoPoint":86,"contacts":19},"Taiyuan","030001",{"type":34,"coordinates":83},[84,85],112.56028,37.86944,{"lat":85,"lon":84},{"facility":28,"status":19,"city":88,"state":19,"zip":89,"country":31,"countryCode":32,"cosmosGeoPoint":90,"geoPoint":94,"contacts":19},"Tianjin","300050",{"type":34,"coordinates":91},[92,93],117.17667,39.14222,{"lat":93,"lon":92},{"facility":28,"status":19,"city":96,"state":19,"zip":97,"country":31,"countryCode":32,"cosmosGeoPoint":98,"geoPoint":102,"contacts":19},"Wuhan","430030",{"type":34,"coordinates":99},[100,101],114.26667,30.58333,{"lat":101,"lon":100},{"facility":28,"status":19,"city":104,"state":19,"zip":105,"country":31,"countryCode":32,"cosmosGeoPoint":106,"geoPoint":110,"contacts":19},"Zhengzhou","450000",{"type":34,"coordinates":107},[108,109],113.64861,34.75778,{"lat":109,"lon":108},{"type":112,"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":123,"type":124},20,"ESTIMATED","INTERVENTIONAL",[127],"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).",[130,131],"Generalized Myasthenia Gravis","gMG",[133,131,134],"generalized myasthenia gravis","ravulizumab","NOT_YET_RECRUITING","2026-06-17",{"date":138,"type":139},"2026-06-22","ACTUAL",{"date":141,"type":124},"2026-07-30",{"date":143,"type":124},"2027-08-27",{"name":5,"class":6},10]