[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":71,"collaborators":19,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":19,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":19,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":95,"whyStopped":19,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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",[27,39,47,55,63],{"facility":28,"status":19,"city":29,"state":19,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":19},"Research Site","Chengdu","610016","China","CN",{"type":34,"coordinates":35},"Point",[36,37],104.06667,30.66667,{"lat":37,"lon":36},{"facility":28,"status":19,"city":40,"state":19,"zip":41,"country":31,"countryCode":32,"cosmosGeoPoint":42,"geoPoint":46,"contacts":19},"Dongguan","523059",{"type":34,"coordinates":43},[44,45],113.74866,23.01797,{"lat":45,"lon":44},{"facility":28,"status":19,"city":48,"state":19,"zip":49,"country":31,"countryCode":32,"cosmosGeoPoint":50,"geoPoint":54,"contacts":19},"Shanghai","201107",{"type":34,"coordinates":51},[52,53],121.45806,31.22222,{"lat":53,"lon":52},{"facility":28,"status":19,"city":56,"state":19,"zip":57,"country":31,"countryCode":32,"cosmosGeoPoint":58,"geoPoint":62,"contacts":19},"Wenzhou","325000",{"type":34,"coordinates":59},[60,61],120.66682,27.99942,{"lat":61,"lon":60},{"facility":28,"status":19,"city":64,"state":19,"zip":65,"country":31,"countryCode":32,"cosmosGeoPoint":66,"geoPoint":70,"contacts":19},"Wuhan","430030",{"type":34,"coordinates":67},[68,69],114.26667,30.58333,{"lat":69,"lon":68},{"type":72,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100635802","phase-3-efficacy-safety-pharmacokinetics-pharmacodynamics-and-immunogenicity-study-of-ravulizumab-in-chinese-adults-with-neuromyelitis-optica-spectrum-disorder-nmosd-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":84,"type":85},21,"ESTIMATED","INTERVENTIONAL",[88],"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).",[91,92],"NMOSD","Neuromyelitis Optica Spectrum Disorder",[9,91,94],"Neuromyelitis optica spectrum disorder","NOT_YET_RECRUITING","2026-06-17",{"date":98,"type":99},"2026-06-18","ACTUAL",{"date":101,"type":85},"2026-08-31",{"date":103,"type":85},"2028-10-31",{"name":5,"class":6},5]