Clinical trial NCT03320265: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arterial Inflammation
Cardiovascular Diseases
Keywords: Phosphorylcholine human monoclonal antibody
Lipoprotein a
Lead sponsor: Athera Biotechnologies AB
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Monocyte function
timeFrame: From baseline (Day 1) to visit 11 (Day 85)
Secondary outcomes:
measure: Arterial inflammation
timeFrame: From baseline (Day 1) to visit 11 (Day 85)
measure: Arterial stiffness
timeFrame: From baseline (Day 1) to visit 11 (Day 85)
measure: Adverse events (AEs)/serious AEs (SAEs)
timeFrame: From baseline (Day 1) to visit 11 (Day 85)
measure: Vital signs, height
timeFrame: At screening (Day -63 to -1)
measure: Vital signs, body weight
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: Vital signs, blood pressure
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: Vital signs, hear rate
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: Vital signs, body temperature
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: Physical examination including review of all organ systems
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: Electrocardiogram (ECG), PR (PQ)
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: ECG, QRS
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: ECG, QT
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
measure: ECG, QTcF
timeFrame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Department of Vascular Medicine, Academic Medical Center
city: Uppsala
country: Sweden
facility: CTC Clinical Trial Consultants AB
Study officials:
affiliation: Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
name: Eric SG Stroes, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: