YN001-004 in Patients With Coronary Atherosclerosis in Australia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Inno Medicine Co., Ltd.
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the purposes, features, and methods of the study, and sign the ICF before performing any assessment.
Male or female Australia patients between 18 and 75 years.
Patients diagnosed with coronary atherosclerosis, and at least 1 vessel with diameter stenosis determined by coronary computed tomography angiography (CTA).
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.
Disqualifiers
Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
Previously received YN001.
Any type of vaccination within 4 weeks prior to randomization.
Contraindication for coronary CTA (e.g., known history of anaphylactic contrast reactions).
Trial design
Design model
Parallel
Treatments tested in this trial
Dose 1 YN001
DrugDose 1 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.
Dose 2 YN001
DrugDose 2 YN001 will be administered on Day 1 of each week from Week 1 to Week 13, 13 times in total.
Evolocumab
DrugEvolocumab 140 mg will be administered subcutaneously every 2 weeks.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Dose 1 treatment armExperimental treatment 2 interventions
Group B: Dose 2 treatment armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Changes in coronary plaque characteristics (volume and composition)
Evaluating YN001 on top of evolocumab therapy in changing coronary plaque volume assessed by coronary computed tomography angiography (CCTA).
Time frame
From baseline to Week 13Secondary outcomes
1
Change in mean of mean carotid IMT
Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.
Time frame
From baseline to Week 132
Change in mean of mean carotid IMT
Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.
Time frame
From baseline to Week 53
Change in mean of mean carotid IMT
Evaluating YN001 on top of evolocumab therapy in changing carotid intima-media thickness (IMT) assessed by carotid ultrasound.
Time frame
From baseline to Week 94
Change in mean peri-coronary Fat attenuation index (FAI)
Evaluating YN001 on top of evolocumab therapy in changing inflammation using the peri-coronary FAI value measured by quantitative CTA analysis.
Time frame
From baseline to Week 13Other outcomes
1
Immunogenicity（ADA） analysis
The proportion of patients who develop anti-drug antibodies (ADA) following drug administration.
Time frame
From Week 1 to Week 132
Immunogenicity （APA）analysis
The proportion of patients with pre-exsiting anti-PEG antibodies (APA), treatment emergent APA or treatment boosted APA following drug administration.
Time frame
From screening to Week 133
Exploratory dose-response analysis of plaque volume
Exploratory dose-response analysis will be performed by comparing the difference of coronary plaque volume changing between 2 different dose levels
Time frame
From Week 1 to Week 134
Exploratory dose-response analysis of AEs
Exploratory dose-response analysis will be performed by comparing the difference of incidence of AEs between 2 different dose levels
Time frame
From Week 1 to Week 13Sponsors and contacts
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Source ClinicalTrials.gov