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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06700720




Registration number
NCT06700720
Ethics application status
Date submitted
14/11/2024
Date registered
22/11/2024
Date last updated
22/11/2024

Titles & IDs
Public title
YN001-004 in Patients With Coronary Atherosclerosis in Australia
Scientific title
A Phase ?a Clinical Study to Evaluate the Efficacy and Safety of YN001 in Patients With Coronary Atherosclerosis in Australia
Secondary ID [1] 0 0
YN001-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Atherosclerotic Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dose 1 YN001
Treatment: Drugs - Dose 2 YN001
Treatment: Drugs - Evolocumab

Experimental: Dose 1 treatment arm - Dose 1 YN001 will be administrated intravenously twice in a week.

Experimental: Dose 2 treatment arm - Dose 2 YN001 will be administrated intravenously weekly.


Treatment: Drugs: Dose 1 YN001
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.

Treatment: Drugs: Dose 2 YN001
Dose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Treatment: Drugs: Evolocumab
Evolocumab 140 mg will be administered subcutaneously every 2 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in coronary plaque characteristics (volume and composition)
Timepoint [1] 0 0
From baseline to Week 13
Secondary outcome [1] 0 0
Change in mean of mean carotid IMT
Timepoint [1] 0 0
From baseline to Week 13
Secondary outcome [2] 0 0
Change in mean of mean carotid IMT
Timepoint [2] 0 0
From baseline to Week 5
Secondary outcome [3] 0 0
Change in mean of mean carotid IMT
Timepoint [3] 0 0
From baseline to Week 9
Secondary outcome [4] 0 0
Change in mean peri-coronary Fat attenuation index (FAI)
Timepoint [4] 0 0
From baseline to Week 13
Secondary outcome [5] 0 0
The safety profile of YN001
Timepoint [5] 0 0
From baseline to Week 15
Secondary outcome [6] 0 0
Plasma concentration of total and free drug
Timepoint [6] 0 0
From Week 1 to Week 13
Secondary outcome [7] 0 0
Population pharmacokinetics (PK)
Timepoint [7] 0 0
From Week 1 to Week 13

Eligibility
Key inclusion criteria
1. Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
2. Male or female Australia patients between 18 and 75 years.
3. Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
4. 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.
5. Willing and able to comply with the requirements of protocol to the best of the patient's and investigator's knowledge.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
2. Previously received YN001.
3. Any type of vaccination within 4 weeks prior to randomization.
4. Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
5. Severe coronary calcification.
6. Multi-vessel severe disease.
7. Recent acute ST-segment elevation myocardial infarction (STEMI) occurred within 2 weeks prior to randomization.
8. 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.
9. Prior treatment with CABG, heart transplantation, SAVR/TAVR, etc., or CABG, heart transplantation, SAVR/TAVR, etc., is required or planned during the study.
10. PCI performed within 4 weeks prior to randomization or PCI is required or planned during study treatment.
11. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction (LVEF) <40%.
12. Recent clinically evident stroke occurred within 6 months prior to randomization (except for TIA).
13. Evidence of major diseases that not recovered within 2 weeks prior to randomization, or major surgery is expected during the study.
14. 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).
15. Systolic blood pressure of =150 mmHg at final screening despite antihypertensive therapy.
16. 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.
17. Presence of renal insufficiency.
18. Poorly controlled (defined by HbA1c > 9%) type 2 diabetes mellitus.
19. 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).
20. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/09/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,Queeslan
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Core Research Group Pty Ltd - Milton
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Milton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Beijing Inno Medicine Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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)
Trial website
https://clinicaltrials.gov/study/NCT06700720
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teresa Chen, PhD
Address 0 0
Beijing Inno Medicine Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jamie Zhang, Master
Address 0 0
Country 0 0
Phone 0 0
861082599080
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06700720