Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Phase 2

Terminated

• Conditions: Arterial Inflammation; Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: PC-mAb

• Registration Number: NCT03320265
• Lead Sponsor: Athera Biotechnologies AB

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study Start: 2017-10-11
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Primary Completion: 2018-03-19
• Status Verified: 2018-07
• Study Completion: 2018-07-03
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to PC-mAb, i.v. infusions
PC-mAb	PC-mAb	Phosphorylcholine human monoclonal antibody, i.v. infusions

Primary Outcome Measures

Name	Time	Method
Monocyte function	From baseline (Day 1) to visit 11 (Day 85)	Change in transendothelial migration (TEM) in monocytes isolated from treated subjects

Secondary Outcome Measures

Name	Time	Method
Arterial inflammation	From baseline (Day 1) to visit 11 (Day 85)	Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)
Arterial stiffness	From baseline (Day 1) to visit 11 (Day 85)	Change in pulse wave velocity (PWV) (m/sec)
Adverse events (AEs)/serious AEs (SAEs)	From baseline (Day 1) to visit 11 (Day 85)	Incidence of AEs/SAEs
Vital signs, height	At screening (Day -63 to -1)	in cm
Vital signs, body weight	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	in kg
Vital signs, blood pressure	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	in mmHg
Vital signs, hear rate	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	in bpm
Vital signs, body temperature	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	in °C
Physical examination including review of all organ systems	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	Any abnormalities will be recorded
Electrocardiogram (ECG), PR (PQ)	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
ECG, QRS	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
ECG, QT	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
ECG, QTcF	At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)	12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

Trial Locations

Locations (2)

Department of Vascular Medicine, Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

CTC Clinical Trial Consultants AB; 🇸🇪 Uppsala, Sweden