Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT06700720
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2024-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
YN001-004 in Patients With Coronary Atherosclerosis in Australia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunogenicity（ADA） analysis', 'timeFrame': 'From Week 1 to Week 13', 'description': 'The proportion of patients who develop anti-drug antibodies (ADA) following drug administration.'}, {'measure': 'Immunogenicity （APA）analysis', 'timeFrame': 'From screening to Week 13', 'description': 'The proportion of patients with pre-exsiting anti-PEG antibodies (APA), treatment emergent APA or treatment boosted APA following drug administration.'}, {'measure': 'Exploratory dose-response analysis of plaque volume', 'timeFrame': 'From Week 1 to Week 13', 'description': 'Exploratory dose-response analysis will be performed by comparing the difference of coronary plaque volume changing between 2 different dose levels'}, {'measure': 'Exploratory dose-response analysis of AEs', 'timeFrame': 'From Week 1 to Week 13', 'description': 'Exploratory dose-response analysis will be performed by comparing the difference of incidence of AEs between 2 different dose levels'}], 'primaryOutcomes': [{'measure': 'Changes in coronary plaque characteristics (volume and composition)', 'timeFrame': 'From baseline to Week 13', 'description': 'Evaluating YN001 on top of evolocumab therapy in changing coronary plaque volume assessed by coronary computed tomography angiography (CCTA).'}], 'secondaryOutcomes': [{'measure': 'Change in mean of mean carotid IMT', 'timeFrame': 'From baseline to Week 13', 'description': 'Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.'}, {'measure': 'Change in mean of mean carotid IMT', 'timeFrame': 'From baseline to Week 5', 'description': 'Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.'}, {'measure': 'Change in mean of mean carotid IMT', 'timeFrame': 'From baseline to Week 9', 'description': 'Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.'}, {'measure': 'Change in mean peri-coronary Fat attenuation index (FAI)', 'timeFrame': 'From baseline to Week 13', 'description': 'Evaluating YN001 on top of evolocumab therapy in changing inflammation using the peri-coronary FAI value measured by quantitative CTA analysis.'}, {'measure': 'The safety profile of YN001', 'timeFrame': 'From baseline to Week 15', 'description': 'Incidence of Adverse events (AEs)/Serious adverse events (SAEs)'}, {'measure': 'Plasma concentration of total and free drug', 'timeFrame': 'From Week 1 to Week 13', 'description': 'Plasma concentration of total and free drug at pre-dose (0 h) and at the end of infusion'}, {'measure': 'Population pharmacokinetics (PK)', 'timeFrame': 'From Week 1 to Week 13', 'description': 'Plasma PK parameter (AUC) and patient covariates of interest will be evaluated graphically and in the population PK model.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Atherosclerosis', 'Plaque regression'], 'conditions': ['Coronary Artery Disease', 'Coronary Atherosclerotic Disease']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety of intravenously administered YN001 in patients with coronary atherosclerosis in Australia. This study will be conducted in eligible participants with a diagnosis of coronary atherosclerosis, and at least 1 coronary artery is blocked determined by coronary computed tomography angiography (CCTA)', 'detailedDescription': 'This is a multicenter, randomized, open label, parallel-group, proof of concept study. It is designed to determine if the study drug, called YN001, administered in addition to evolocumab can effectively reduce the total amount of plaque formed in the coronary artery as measured by CCTA from baseline to week 13.\n\nA total of 12 patients with coronary atherosclerosis are expected to be enrolled and will be randomly assigned in a 1:1 ratio to 1 of 2 YN001 treatment arms (6 patients per arm) with 2 different dose levels for 12 weeks.\n\nThe study will be comprised of a maximum 41-day screening period (Day -42-Day -2), a baseline period (Day-1), a treatment and observation period (W1D1- W13D7), and a safety follow-up period (14 days post last dose).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.\n2. Male or female Australia patients between 18 and 75 years.\n3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).\n4. Female patients must be non-pregnant and non-lactating, and females of childbearing potential (including a female partner of a male patient) must agree to use 1 effective contraception method from the screening period to 3 months after receiving their last dose of the study drug. In addition, male patients must be willing to refrain from sperm donation during this time.\n5. Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.\n\nExclusion Criteria:\n\n1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.\n2. Previously received YN001.\n3. Any type of vaccination within 4 weeks prior to randomization.\n4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).\n5. Severe coronary calcification.\n6. Multi-vessel severe disease.\n7. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.\n8. Relapse and highly symptomatic arrhythmia uncontrolled by drugs within the past 3 months, such as ventricular tachycardia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia.\n9. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.\n10. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.\n11. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) \\<40%.\n12. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).\n13. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.\n14. Presenting with history of malignancy (except in patients who have been disease-free \\>5 years; or whose only malignancy has been basal or squamous cell skin carcinoma).\n15. Systolic blood pressure of ≥150 mmHg at final screening despite antihypertensive therapy.\n16. Active liver disease or hepatic dysfunction defined by any of ALT, AST, or total bilirubin \\> 2 times upper limit of normal (ULN) at final screening.\n17. Presence of renal insufficiency.\n18. Poorly controlled (defined by HbA1c \\> 9%) type 2 diabetes mellitus.\n19. A positive hepatitis B surface antigen (HBsAg), or positive antibody against hepatitis C virus (anti-HCV) or human immunodeficiency virus (anti-HIV), or positive treponema pallidum antibody (TP-Ab).\n20. Presence of any other diseases or conditions (apart from those outlined above) that, in the opinion of the investigator, would make it unsuitable for the patient to participate in this study."}, 'identificationModule': {'nctId': 'NCT06700720', 'briefTitle': 'YN001-004 in Patients With Coronary Atherosclerosis in Australia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Inno Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ⅱa Clinical Study to Evaluate the Efficacy and Safety of YN001 in Patients With Coronary Atherosclerosis in Australia', 'orgStudyIdInfo': {'id': 'YN001-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 treatment arm', 'description': 'Dose 1 YN001 will be administrated intravenously twice in a week.', 'interventionNames': ['Drug: Dose 1 YN001', 'Drug: Evolocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 treatment arm', 'description': 'Dose 2 YN001 will be administrated intravenously weekly.', 'interventionNames': ['Drug: Dose 2 YN001', 'Drug: Evolocumab']}], 'interventions': [{'name': 'Dose 1 YN001', 'type': 'DRUG', 'description': 'Dose 1 YN001 will be administered on Day 1 and Day 5 of each week from Week 1 to Week 12, and on Day 1 of Week 13, 25 times in total.', 'armGroupLabels': ['Dose 1 treatment arm']}, {'name': 'Dose 2 YN001', 'type': 'DRUG', 'description': 'Dose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.', 'armGroupLabels': ['Dose 2 treatment arm']}, {'name': 'Evolocumab', 'type': 'DRUG', 'otherNames': ['Repatha®'], 'description': 'Evolocumab 140 mg will be administered subcutaneously every 2 weeks.', 'armGroupLabels': ['Dose 1 treatment arm', 'Dose 2 treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Canberra', 'state': 'Australian Capital Territory', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Walter Abhayaratna, PhD', 'role': 'CONTACT'}], 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'zip': '1125', 'city': 'Albury', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Fiore', 'role': 'CONTACT'}], 'facility': 'Albury Wodonga Private Hospital', 'geoPoint': {'lat': -36.07482, 'lon': 146.92401}}, {'city': 'Milton', 'state': 'Queesland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Colquhoun, PhD', 'role': 'CONTACT'}], 'facility': 'Core Research Group Pty Ltd', 'geoPoint': {'lat': -27.47039, 'lon': 153.00312}}, {'zip': '3025', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Walsh', 'role': 'CONTACT'}], 'facility': 'Altona Clinical Research', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3199', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Szto', 'role': 'CONTACT'}], 'facility': 'Peninsula Heart Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Jamie Zhang, Master', 'role': 'CONTACT', 'email': 'zhangjingmei@innovmedicine.com', 'phone': '861082599080'}], 'overallOfficials': [{'name': 'Teresa Chen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Inno Medicine Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Inno Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}