Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2018-07-03

Brief Summary

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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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Detailed Description

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Conditions

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Arterial Inflammation Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PC-mAb

Phosphorylcholine human monoclonal antibody, i.v. infusions

Group Type EXPERIMENTAL

PC-mAb

Intervention Type DRUG

Monthly treatment for 3 months (4 administrations)

Placebo

Placebo to PC-mAb, i.v. infusions

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Monthly treatment for 3 months (4 administrations)

Interventions

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PC-mAb

Monthly treatment for 3 months (4 administrations)

Intervention Type DRUG

Placebo

Monthly treatment for 3 months (4 administrations)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Lp(a) above 50 mg/dL at screening

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No