[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617628":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":49,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Biocad","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BCD-281","EXPERIMENTAL","Subjects will receive 300 mg (for the first two infusions) and 600 mg via subsequent infusions.",[13],"Biological: BCD-281",{"label":15,"type":16,"description":11,"interventionNames":17},"Ocrelizumab","ACTIVE_COMPARATOR",[18],"Biological: Ocrelizumab",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","anti-CD20 monoclonal antibody",[9],null,{"type":21,"name":15,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Marina Krasnova","CONTACT","+7 (812) 380 49 33","krasnovam@biocad.ru",[34],{"facility":35,"status":36,"city":37,"state":24,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"LLC \"Medis\"","RECRUITING","Nizhny Novgorod","Russia","RU",{"type":41,"coordinates":42},"Point",[43,44],44.00205,56.32867,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":24,"phoneExt":24,"email":24},"Sokolova",{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100617628","phase-3-a-study-of-the-efficacy-and-safety-of-bcd-281-in-patients-with-relapsing-remitting-multiple-sclerosis-100617628",false,"NCT07321093","A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","MUSCAT","Inclusion Criteria:\n\n* Provided written ICF to participate in the study.\n* Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.\n* Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).\n* Relapsing-remitting multiple sclerosis.\n* The total EDSS score 0-5.5 inclusive.\n* Documentary evidence of the following at the time of signing the ICF:\n\n  1. at least one relapse within the last12 months, and\u002For\n  2. 2 relapses within the last 24 months, and\u002For\n  3. at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.\n* Presence of IgG antibodies to the Varicella-Zoster virus.\n* Neurological stability for 30 days prior to signing the ICF.\n* Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.\n* The ability of the subject to follow the Protocol procedures, according to the Investigator.\n* Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive MS.\n* MS duration of more than 10 years with EDSS score of ≤2.0 at screening.\n* Malignant form of MS.\n* Other medical conditions that can affect the assessment of clinical picture of the MS.\n* Inability to obtain high-quality MRI images and\u002For the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.\n* Any comorbidities requiring treatment with systemic glucocorticoids and\u002For immunosuppressive drugs for the duration of the study, with the exception of MS.\n* History of progressive multifocal leukoencephalopathy.\n* Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.\n* Concomitant diseases and\u002For conditions that may affect the assessment of the clinical picture of the underlying disease and\u002For significantly increase the risk of AEs during the study.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction.\n* History of severe depression and\u002For a Beck Depression Inventory score of ≥16 at screening examination.\n* History of a malignant disease within 5 years prior to screening.\n* A diagnosis of HIV infection, hepatitis B or C .\n* Inability to provide the subject with venous access.\n* Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.\n* A history of severe allergic or anaphylactic reactions to humanized and\u002For murine monoclonal antibodies.\n* A history of using any prohibited medications or treatments defined in the study protocol.\n* Abnormal laboratory blood values, as specified in the study protocol.","ALL","18 Years","55 Years",{"count":63,"type":64},292,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.",[70],"Relapsing-remitting Multiple Sclerosis (RRMS)",[72,73,74],"Multiple Sclerosis","anti CD20","monoclonal antibody","2025-12-26",{"date":77,"type":78},"2026-01-06","ACTUAL",{"date":80,"type":78},"2025-11-01",{"date":82,"type":64},"2028-12",{"name":5,"class":6},1]