Trial | NCT03320265  Report issue

Title

Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    PC-mAb ...

  • Study Participants

    10
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).
Study Started
Oct 11
2017
Primary Completion
Mar 19
2018
Study Completion
Jul 03
2018
Last Update
Jul 06
2018

Drug PC-mAb

Monthly treatment for 3 months (4 administrations)

Drug Placebo

Monthly treatment for 3 months (4 administrations)

PC-mAb Experimental

Phosphorylcholine human monoclonal antibody, i.v. infusions

Placebo Placebo Comparator

Placebo to PC-mAb, i.v. infusions

Criteria 

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
No Results Posted