[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486976":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":44,"studyPopulation":44,"armGroups":53,"interventions":74,"overallOfficials":44,"centralContacts":90,"locations":96,"responsibleParty":114,"collaborators":44,"id":116,"slug":44,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":44,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":44,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":44,"overallStatus":99,"whyStopped":44,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percent Change From Baseline in LDL-C at Week 12","Percent Change From Baseline in LDL-C at Week 12 in statin intolerance subjects","Baseline and week 12",{"measure":10,"description":14,"timeFrame":12},"Percent Change From Baseline in LDL-C at Week 12 in ITT subjects",[16,19,23,26,30,33],{"measure":17,"description":18,"timeFrame":12},"Change From Baseline in LDL-C at Week 12","Change From Baseline in LDL-C at Week 12 in statin intolerance and ITT subjects",{"measure":20,"description":21,"timeFrame":22},"Percent Change From Baseline in LDL-C at Week 24,52","Percent Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects","Baseline and week 24,52",{"measure":24,"description":25,"timeFrame":22},"Change From Baseline in LDL-C at Week 24,52","Change From Baseline in LDL-C at Week 24,52 in statin intolerance and ITT subjects",{"measure":27,"description":28,"timeFrame":29},"Percent Change From Baseline in other lipid parameters such as non-HDL-C, ApoB, TC, et al. at Week 12, 24, 52","Percent Change From Baseline in other lipid parameters at Week 12, 24, 52 in statin intolerance and ITT subjects","Baseline and week 12, 24, 52",{"measure":31,"description":32,"timeFrame":29},"Percentage of Participants With LDL-C Less Than 1.8 mmol\u002FL(70 mg\u002FdL)","Percentage of Participants With LDL-C Less Than 1.8 mmol\u002FL(70 mg\u002FdL) at Week 12, 24, 52 in statin intolerance and ITT subjects",{"measure":34,"description":35,"timeFrame":29},"Percentage of Participants With Full Administration of JS002","Percentage of Participants With Full Administration of JS002 at Weeks 12, 24, 52 in statin intolerance and ITT subjects",[37],{"measure":38,"description":39,"timeFrame":40},"Number of Participants with anti-drug antibodies (ADAs)","Serum samples were analyzed for ADA. Positive samples were subsequently tested for neutralizing antibodies.","From baseline to week 60",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":44,"timePerspective":44,"maskingInfo":46},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":47,"maskingDescription":44,"whoMasked":48},"QUADRUPLE",[49,50,51,52],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[54,60,65,70],{"label":55,"type":56,"description":57,"interventionNames":58},"JS002 150mg Q2W","EXPERIMENTAL","JS002 150mg Q2W SC for 52 weeks",[59],"Drug: JS002",{"label":61,"type":62,"description":63,"interventionNames":64},"JS002 450mg Q4W","PLACEBO_COMPARATOR","JS002 450mg Q4W SC for 52 weeks",[59],{"label":66,"type":62,"description":67,"interventionNames":68},"Placebo Q2W","Placebo Q2W SC for 12 weeks, then switch to JS002 150mg Q2W SC for 40 weeks",[69],"Drug: Placebo",{"label":71,"type":62,"description":72,"interventionNames":73},"Placebo Q4W","Placebo Q4W SC for 12 weeks, then switch to JS002 450mg Q4W SC for 40 weeks",[69],[75,80,83,87],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":44},"DRUG","JS002","JS002 will be administered per auto-injector. Participants will receive JS002 every 2 weeks subcutaneously.",[55],{"type":76,"name":77,"description":81,"armGroupLabels":82,"otherNames":44},"JS002 will be administered per auto-injector. Participants will receive JS002 every 4 weeks subcutaneously.",[61],{"type":76,"name":84,"description":85,"armGroupLabels":86,"otherNames":44},"Placebo","Placebo will be administered per auto-injector. Participants will receive placebo every 2 weeks subcutaneously.",[66],{"type":76,"name":84,"description":88,"armGroupLabels":89,"otherNames":44},"Placebo will be administered per auto-injector. Participants will receive placebo every 4 weeks subcutaneously.",[71],[91],{"name":92,"role":93,"phone":94,"phoneExt":44,"email":95},"Qiu'e Wan, PM","CONTACT","86 17710342522","qiu.e_wan@junshipharma.com",[97],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Peking University Third Hospital","RECRUITING","Beijing","Beijing Municipality","100191","China","CN",{"type":106,"coordinates":107},"Point",[108,109],116.39723,39.9075,{"lat":109,"lon":108},[112],{"name":113,"role":93,"phone":44,"phoneExt":44,"email":44},"Yida Tang, Doctor",{"type":115,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100486976",false,"NCT05621070","Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia","A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age 18\\~80 years old\n3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening\n4. Fasting TG≤4.5mmol\u002FL by central laboratory at screening\n5. Statin intolerance subject must have a history of statin intolerance as evidenced\n\nExclusion Criteria:\n\n1. History of hemorrhagic stroke\n2. NYHA III or IV heart failure, or known LVEF\\\u003C 30% within 1 year before randomization\n3. Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization\n4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization\n5. Planned cardiac surgery or revascularization\n6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \\> 160 mmHg or diastolic BP (DBP) \\> 100 mmHg\n7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \\> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)\n8. Others factors not suitable for participation judged by PI","ALL","18 Years","80 Years",{"count":126,"type":127},582,"ESTIMATED","INTERVENTIONAL",[130],"PHASE3","JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK\u002FPD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.\n\nIn this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150\u002F450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.",[133],"Primary Hypercholesterolaemia and Mixed Dyslipidemia","2024-09-09",{"date":136,"type":137},"2024-09-19","ACTUAL",{"date":139,"type":137},"2023-02-03",{"date":141,"type":127},"2024-09-30",{"name":5,"class":6},1]