[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":70,"collaborators":19,"id":72,"slug":19,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":19,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":19,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":93,"whyStopped":19,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Alexion Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ravulizumab","EXPERIMENTAL","Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance treatment dose on Day 15 and every 8 weeks (q8w) thereafter for up to 50 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],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":19},"Research Site","Chengdu","610016","China",{"type":33,"coordinates":34},"Point",[35,36],104.06667,30.66667,{"lat":36,"lon":35},{"facility":28,"status":19,"city":39,"state":19,"zip":40,"country":31,"cosmosGeoPoint":41,"geoPoint":45,"contacts":19},"Dongguan","523059",{"type":33,"coordinates":42},[43,44],113.74866,23.01797,{"lat":44,"lon":43},{"facility":28,"status":19,"city":47,"state":19,"zip":48,"country":31,"cosmosGeoPoint":49,"geoPoint":53,"contacts":19},"Shanghai","201107",{"type":33,"coordinates":50},[51,52],121.45806,31.22222,{"lat":52,"lon":51},{"facility":28,"status":19,"city":55,"state":19,"zip":56,"country":31,"cosmosGeoPoint":57,"geoPoint":61,"contacts":19},"Wenzhou","325000",{"type":33,"coordinates":58},[59,60],120.66682,27.99942,{"lat":60,"lon":59},{"facility":28,"status":19,"city":63,"state":19,"zip":64,"country":31,"cosmosGeoPoint":65,"geoPoint":69,"contacts":19},"Wuhan","430030",{"type":33,"coordinates":66},[67,68],114.26667,30.58333,{"lat":68,"lon":67},{"type":71,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100635802",false,"NCT07557420","Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)","A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)","Key Inclusion (essential)\n\n* Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.\n* Disease activity: ≥1 attack\u002Frelapse in the past 12 months.\n* Disability: EDSS ≤7.\n* Background therapy: If on IST and\u002For oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration\u002Fdose rules to be confirmed at screening.)\n* Body weight: ≥40 kg.\n* Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day 1.\n\nKey Exclusion (essential)\n\n* Pregnancy\u002Flactation: Pregnant, breastfeeding, or intending to conceive during the study.\n* Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1.\n* Hypersensitivity: To murine proteins or ravulizumab excipients.\n* Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation\u002Fassessment.\n* Viral infections: Known HIV, active HBV, or active HCV.\n* Prior\u002Fconcomitant immunomodulatory treatments:\n\n  * B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening.\n  * Mitoxantrone or satralizumab within 3 months before Screening.\n  * IVIg within 3 weeks before Screening.\n  * Any prior or current complement inhibitor.\n\nNote: Other protocol-defined criteria may apply and should be verified during full eligibility review.","ALL","18 Years","130 Years",{"count":82,"type":83},21,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).",[89,90],"NMOSD","Neuromyelitis Optica Spectrum Disorder",[9,89,92],"Neuromyelitis optica spectrum disorder","NOT_YET_RECRUITING","2026-06-17",{"date":96,"type":97},"2026-06-18","ACTUAL",{"date":99,"type":83},"2026-08-31",{"date":101,"type":83},"2028-10-31",{"name":5,"class":6},5]