Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04515927
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2020-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of effectiveness', 'timeFrame': 'JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration', 'description': 'Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipemia']}, 'descriptionModule': {'briefSummary': 'JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled.\n\nEach subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥12 and ≤75 years old;\n3. Weight ≥40kg at the time of screening\n4. Patients diagnosed with HoFH\n5. Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening\n6. Fasting triglycerides ≤4.5 mmol/L;\n\nExclusion Criteria:\n\n1. History of NYHA class III-IV heart failure or EF\\<30%\n2. History of uncontrolled arrhythmia within 3 months\n3. History of MI,UA, PCI or CABG, stroke within 3 months.\n4. History of DVT or pulmonary embolism within 3 months.\n5. Planned cardiac surgery or revascularization.\n6. Uncontrolled hypertension.\n7. Uncontrolled diabetes mellitius (HbA1c\\>8.0%）.\n8. Other conditions that the researchers considered inappropriate to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04515927', 'briefTitle': 'To Evaluate the Efficacy and Safety of JS002 in HoFH Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'JS002-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.', 'interventionNames': ['Drug: JS002']}], 'interventions': [{'name': 'JS002', 'type': 'DRUG', 'description': 'Biological: JS002 Administered by subcutaneous injection', 'armGroupLabels': ['subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}