[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558903":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":25,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":25},{"fullName":5,"class":6},"ImmuneOnco Biopharmaceuticals (Shanghai) Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IMC-002","EXPERIMENTAL","intravenous injection of 0.8mg\u002Fkg、1.2mg\u002Fkg",[13],"Drug: IMC-002",{"label":15,"type":16,"description":17,"interventionNames":18},"mycophenolate mofetil， MMF","ACTIVE_COMPARATOR","mycophenolate mofetil will be administrated as monotherapy control for 0.2g daily oral.",[19],"Drug: mycophenolate mofetil， MMF",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","intravenous injection: Weekly administered for a period of first 4 weeks, then rest for 20 weeks. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"daily oral 0.2g",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"jinhua zhou","CONTACT","02138016387","jinhua.zhou@immuneonco.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100558903","phase-1-a-study-to-evaluate-imc-002-in-neuromyelitis-optica-spectrum-disorder-nmosd-patients-100558903",false,"NCT06557174","A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients","A Phase Ib\u002FIII Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients","Inclusion Criteria:\n\n* Age 18 to 70 years, inclusive, at the time of informed consent\n* Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria\n* Confirmation of NMOSD diagnosis with AQP4+ antibodies\n* The EDSS score should be ≤7.0\n* Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening\n\nExclusion Criteria:\n\n* Have received rituximab or other anti-CD20 drugs treatment within 6 months\n* Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.\n* Females who are pregnant or lactating.\n* Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).","ALL","18 Years","70 Years",{"count":48,"type":49},116,"ESTIMATED","INTERVENTIONAL",[52,53],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.",[56],"Neuromyelitis Optica Spectrum Disorder (NMOSD)","NOT_YET_RECRUITING","2024-08-15",{"date":60,"type":61},"2024-08-16","ACTUAL",{"date":63,"type":49},"2024-10-10",{"date":65,"type":49},"2026-07-10",{"name":67,"class":6},"ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd."]