Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-04-22 @ 1:37 AM
Study NCT ID:
NCT05325203
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2022-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of subjects who develop detectable anti-drug antibodies (ADAs)', 'timeFrame': 'from baseline to 32 weeks', 'description': 'ADA was quantified using the Bridging-ECLIA'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'LDL-C was quantified using the enzymatic colorimetric assay'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'LDL-C was quantified using the enzymatic colorimetric assay'}, {'measure': 'Percentage changes From Baseline in the Total Cholesterol at week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'TC was quantified using the enzymatic colorimetric assay'}, {'measure': 'Absolute changes From Baseline in the Total Cholesterol at week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'TC was quantified using the enzymatic colorimetric assay'}, {'measure': 'Percentage changes From Baseline in Non-HDL-C at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Non-HDL-C was quantified using the Calculation,TC minus HDL-C'}, {'measure': 'Absolute changes From Baseline in Non-HDL-C at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Non-HDL-C was quantified using the Calculation,TC minus HDL-C'}, {'measure': 'Percentage changes From Baseline in Apo B at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Apo B was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Absolute changes From Baseline in Apo B at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Apo B was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Percentage changes From Baseline in Lp(a) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Lp(a) was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Absolute changes From Baseline in Lp(a) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Lp(a) was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Percentage changes From Baseline in HDL-C at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HDL-C was quantified using the enzymatic colorimetric assay'}, {'measure': 'Absolute changes From Baseline in HDL-C at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'HDL-C was quantified using the enzymatic colorimetric assay'}, {'measure': 'Percentage changes From Baseline in Apo A1 at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Apo A1 was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Absolute changes From Baseline in Apo A1 at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Apo A1 was quantified using the turbidimetric immunoassay(TIA)'}, {'measure': 'Percentage changes From Baseline in TG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'TG was quantified using the enzymatic colorimetric assay'}, {'measure': 'Absolute changes From Baseline in TG at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'TG was quantified using the enzymatic colorimetric assay'}, {'measure': 'The ratio of TC/HDL - C', 'timeFrame': 'Baseline and Week 24', 'description': 'Calculation'}, {'measure': 'The ratio of Apo B/Apo A1', 'timeFrame': 'Baseline and Week 24', 'description': 'Calculation'}, {'measure': 'Percentage of Participants With 50% or Greater Reduction in LDL-C From Baseline at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Calculation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heterozygous Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '39999660', 'type': 'DERIVED', 'citation': 'Lin J, Ji Y, Wang G, Ma X, Yao Z, Han X, Chen J, Chen J, Huang W, Xu G, Peng D, Yan P, Qiao P, He Y, Tang Y, Wang M, Zhang M, Yu J, Hao Y, Ma C. Efficacy and safety of ongericimab in Chinese patients with heterozygous familial hypercholesterolemia: A randomized, double-blind, placebo-controlled phase 3 trial. Atherosclerosis. 2025 Apr;403:119120. doi: 10.1016/j.atherosclerosis.2025.119120. Epub 2025 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).', 'detailedDescription': 'A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planned to be enrolled. Each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. To evaluate the lipid-lowering efficacy of subcutaneous injection of JS002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . Subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to JS002 150 mg Q2W or JS002 450 mg Q4W or matched placebo to receive the study drug (JS002) or placebo subcutaneously for 24 weeks.\n\ntreatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent.\n2. Males and females ≥ 18 to ≤ 80 years of age\n3. DLCN\\>8 in HeFH\n4. Stable lipid-lowering therapies for at least 4 weeks\n5. Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening\n6. Triglyceride≤4.5 mmol/L（400 mg/dL）;\n\nExclusion Criteria:\n\n1. HoFH or meet the diagnostic criteria of HoFH\n2. New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \\< 30%\n3. History of uncontrolled arrhythmia within 90 days\n4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization\n5. Planned cardiac surgery or revascularization.\n6. Uncontrolled diabetes mellitius (HbA1c\\>8.0%）.\n7. Uncontrolled hypertension.\n8. Other conditions that the researchers considered inappropriate to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05325203', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody Injection in Subjects With Heterozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'JS002-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JS002 150mg Q2W for 24 weeks', 'description': '40 patients will be enrolled in this arm', 'interventionNames': ['Biological: Ongericimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo 150mg Q2W for 24 weeks', 'description': '20 patients will be enrolled in this arm', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'JS002 450mg Q4W for 24 weeks', 'description': '40 patients will be enrolled in this arm', 'interventionNames': ['Biological: Ongericimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo 450mg Q4W for 24 weeks', 'description': '20 patients will be enrolled in this arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ongericimab', 'type': 'BIOLOGICAL', 'otherNames': ['JS002'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['JS002 150mg Q2W for 24 weeks', 'JS002 450mg Q4W for 24 weeks']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['placebo 150mg Q2W for 24 weeks', 'placebo 450mg Q4W for 24 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital Capital Medical University City:Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}