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Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Primary Purpose

Arterial Inflammation, Cardiovascular Diseases

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

PC-mAb

Placebo

About this trial

This is an interventional treatment trial for Arterial Inflammation focused on measuring Phosphorylcholine human monoclonal antibody, Lipoprotein a

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major inclusion criterion:

Lp(a) above 50 mg/dL at screening

Major exclusion criteria:

Medical history of myocardial infarction (MI) or stroke within 12 months of screening
Ongoing or paroxysmal atrial fibrillation
Clinically overt heart failure
Hypertension defined as ≥180/100 mmHg
Diabetes mellitus
Systemic autoimmune diseases requiring treatment
Cancer, excluding basal cell carcinoma, within the last five years

Sites / Locations

Department of Vascular Medicine, Academic Medical Center
CTC Clinical Trial Consultants AB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PC-mAb

Placebo

Arm Description

Phosphorylcholine human monoclonal antibody, i.v. infusions

Placebo to PC-mAb, i.v. infusions

Outcomes

Primary Outcome Measures

Monocyte function

Change in transendothelial migration (TEM) in monocytes isolated from treated subjects

Secondary Outcome Measures

Arterial inflammation

Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)

Arterial stiffness

Change in pulse wave velocity (PWV) (m/sec)

Adverse events (AEs)/serious AEs (SAEs)

Incidence of AEs/SAEs

Vital signs, height

in cm

Vital signs, body weight

in kg

Vital signs, blood pressure

in mmHg

Vital signs, hear rate

in bpm

Vital signs, body temperature

in °C

Physical examination including review of all organ systems

Any abnormalities will be recorded

Electrocardiogram (ECG), PR (PQ)

12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

ECG, QRS

12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

ECG, QT

12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

ECG, QTcF

12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

Full Information

NCT ID

NCT03320265

First Posted

October 10, 2017

Last Updated

July 4, 2018

Sponsor

Athera Biotechnologies AB

1. Study Identification

Unique Protocol Identification Number

NCT03320265

Brief Title

Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Official Title

Double-blind, Randomised, Placebo-controlled, Multicentre, Phase IIa Study to Investigate the Effect of PC-mAb on Arterial Inflammation in Subjects With Elevated Lipoprotein a

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Terminated

Why Stopped

Terminated

Study Start Date

October 11, 2017 (Actual)

Primary Completion Date

March 19, 2018 (Actual)

Study Completion Date

July 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Athera Biotechnologies AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Inflammation, Cardiovascular Diseases

Keywords

Phosphorylcholine human monoclonal antibody, Lipoprotein a

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PC-mAb

Arm Type

Experimental

Arm Description

Phosphorylcholine human monoclonal antibody, i.v. infusions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to PC-mAb, i.v. infusions

Intervention Type

Drug

Intervention Name(s)

PC-mAb

Intervention Description

Monthly treatment for 3 months (4 administrations)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Monthly treatment for 3 months (4 administrations)

Primary Outcome Measure Information:

Title

Monocyte function

Description

Change in transendothelial migration (TEM) in monocytes isolated from treated subjects

Time Frame

From baseline (Day 1) to visit 11 (Day 85)

Secondary Outcome Measure Information:

Title

Arterial inflammation

Description

Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)

Time Frame

From baseline (Day 1) to visit 11 (Day 85)

Title

Arterial stiffness

Description

Change in pulse wave velocity (PWV) (m/sec)

Time Frame

From baseline (Day 1) to visit 11 (Day 85)

Title

Adverse events (AEs)/serious AEs (SAEs)

Description

Incidence of AEs/SAEs

Time Frame

From baseline (Day 1) to visit 11 (Day 85)

Title

Vital signs, height

Description

in cm

Time Frame

At screening (Day -63 to -1)

Title

Vital signs, body weight

Description

in kg

Time Frame