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| ID | Type | Description | Link |
|---|---|---|---|
| IND 157167 | Registry Identifier | Beijing Inno Medicine Co., Ltd. |
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| Name | Class |
|---|---|
| The TIMI Study Group | OTHER |
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This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.
This is a multinational, multicenter, randomized, parallel, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of intravenously administered YN001 compared with placebo in participants with coronary atherosclerosis who are receiving background therapy for CV risk factors management.
A total of 456 participants are expected to be enrolled. The study will consist of a maximum 12-week screening/Baseline period, followed by a 12-week blinded treatment period, a 30-day safety follow-up, and a long-term follow-up period through Week 96 (approximately 2 years after randomization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 YN001/Placebo 40mg | Experimental | Dose 1 YN001/Placobo 40mg will be administrated intravenously weekly |
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| Dose 2 YN001/Placebo 20mg | Experimental | Dose 2 YN001/Placebo 20mg will be administrated intravenously weekly |
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| Dose 3 YN001/Placebo 0mg | Placebo Comparator | Dose 3 YN001/Placebo 0mg will be administrated intravenously weekly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YN001/Placebo 40mg | Drug | Dose 1 YN001/Placebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in coronary NCPV at Week 13 | Relative change in coronary NCPV from baseline to Week 13 as determined by coronary computed tomography angiography (CCTA) | Baseline to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in carotid intima-media thickness (IMT) at Week 13 | Absolute change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound. | From baseline to Week 13 |
| Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9 |
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Inclusion Criteria:
1) Have clinically evident atherosclerotic CV disease (ASCVD) 2) Meet at least two of the following criteria at screening/baseline, as evidenced by:
A history of Type 2 diabetes requiring treatment with medication,
Aged > 55 years (women) or > 50 years (men),
2 or more of the following atherosclerosis risk factors:
Current cigarette smoker
Hypertension
Estimated glomerular filtration rate (eGFR) 45 to 60 ml/min/1.73m2
4. Known coronary atherosclerosis as evidenced through coronary angiography or CCTA. The following criteria must be met on the core lab CCTA interpretation for the patient to be enrolled: at least one epicardial coronary artery with a lumen stenosis of 25% to 69%, total coronary NCPV is at least 75 mm3, Detectable low-attenuation composition in one or more individual plaques.
5. Female participants must be non-pregnant and non-lactating
6. Willing and able to comply with the requirements of protocol to the best of the participant's and investigator's knowledge.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingmei Zhang, Master | Contact | 0086 010 82599080 | zhangjingmei@innovmedicine.com | |
| Kaiqi Zong, Master | Contact | 0086 010 82599080 | zongkaiqi@innovmedicine.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Chen, PhD | Beijing Inno Medicine Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China |
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A double-blind treatment period of 12 weeks
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Double-blind (Investigator and participants)
| YN001/Placebo 20mg | Drug | YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total. |
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| YN001/Placebo 0mg | Drug | YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total. |
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Absolute change from baseline in carotid intima-media thickness (IMT) at Week 9 |
| From baseline to Week 9 |
| Relative change from baseline in carotid intima-media thickness (IMT) at Week 13 | Relative change in carotid IMT from baseline to Week 13 as determined by carotid ultrasound | From baseline to Week 13 |
| Relative change in the maximum thickness and area of carotid plaque at Week 9, and Week 13 | Relative change in the maximum thickness and area of carotid plaque from baseline to Week 9, and Week 13 as determined by carotid ultrasound | From baseline to Week 9 and Week 13 |
| Relative change in coronary Percent Atheroma Volume (PAV) at Week 13 | Relative change in coronary Percent Atheroma Volume (PAV) from baseline to Week 13 as determined by CCTA | From baseline to Week 13 |
| Relative change in coronary Low Attenuation Plaque Volume(LAPV) at Week 13 | Relative change in coronary LAPV from baseline to Week 13 as determined by CCTA. | From baseline to week 13 |
| Relative changes in coronary NCPV, PAV, TAV, and LAPV from baseline at 48 week | Relative changes in coronary NCPV, PAV, TAV, and LAPV from baseline to Week 48 as determined by CCTA | From baseline to week 48 |
| Absolute change in coronary NCPV at week 13 and week 48 | Absolute change in coronary NCPV from baseline to Week 13 and Week 48 as determined by CCTA | From baseline to week 13 and week 48 |
| Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE) | Time to the first occurrence of the MACE, composite of CV death, myocardial infarction (MI), ischemic stroke, urgent coronary revascularization, or hospitalization for unstable angina | From randomization to Week 96 |
| The safety profile of YN001 | Incidence of treatment emergent adverse event (TEAE)/serious adverse event (SAE)/adverse event of special interest (AESI) | From baseline to Week 13 |
| Immunogenicity (ADA) analysis | Incidence of anti-drug antibodies (ADA) formation | From baseline to Week 13 |
| Immunogenicity (APA) analysis | Incidence of anti-PEG antibodies (APA) formation | From baseline to Week 17 |
| YN001 concentrations analysis in plasma | Sparse blood samples will be collected, and these concentrations are intended to be pooled with other studies to develop/update pharmacometric models | From baseline to Week 13 |
| Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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| Beijing Jishuitan Hospital | Beijing | Beijing Municipality | 100035 | China |
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| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
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| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
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| The First Hospital of Jilin University | Changchun | Jilin | 130033 | China |
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| The People's Hospital of Liaoning Province | Shenyang | Liaoning | 110015 | China |
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| Renji Hospital Shanghai Jiaotong University school of medicine | Shanghai | Shanghai Municipality | 200001 | China |
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| Fudan University-Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
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| Tianjin People's Hospital | Tianjin | Tianjin Municipality | 300121 | China |
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| The Second Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300211 | China |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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