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Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events.
This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC-mAb | Experimental | Phosphorylcholine human monoclonal antibody, i.v. infusions |
|
| Placebo | Placebo Comparator | Placebo to PC-mAb, i.v. infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC-mAb | Drug | Monthly treatment for 3 months (4 administrations) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Monocyte function | Change in transendothelial migration (TEM) in monocytes isolated from treated subjects | From baseline (Day 1) to visit 11 (Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial inflammation | Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT) | From baseline (Day 1) to visit 11 (Day 85) |
| Arterial stiffness |
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Major inclusion criterion:
Major exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric SG Stroes, MD, Prof. | Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Medicine, Academic Medical Center | Amsterdam | 1105 AZ | Netherlands | |||
| CTC Clinical Trial Consultants AB |
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| ID | Term |
|---|---|
| D001167 | Arteritis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
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| Placebo |
| Drug |
Monthly treatment for 3 months (4 administrations) |
|
Change in pulse wave velocity (PWV) (m/sec)
| From baseline (Day 1) to visit 11 (Day 85) |
| Adverse events (AEs)/serious AEs (SAEs) | Incidence of AEs/SAEs | From baseline (Day 1) to visit 11 (Day 85) |
| Vital signs, height | in cm | At screening (Day -63 to -1) |
| Vital signs, body weight | in kg | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Vital signs, blood pressure | in mmHg | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Vital signs, hear rate | in bpm | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Vital signs, body temperature | in °C | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Physical examination including review of all organ systems | Any abnormalities will be recorded | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Electrocardiogram (ECG), PR (PQ) | 12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| ECG, QRS | 12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| ECG, QT | 12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| ECG, QTcF | 12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded | At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) |
| Uppsala |
| 75237 |
| Sweden |