Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03320265
• Other study ID #: ATH3G10-005
• Status: Terminated
• Phase: Phase 2
• Start date: October 11, 2017
• Est. completion date: July 3, 2018

Study information

• Verified date: July 2018
• Source: Athera Biotechnologies AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 3, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Inflammation
• Arteritis
• Cardiovascular Diseases
• Inflammation

Intervention

Drug:
• PC-mAb
Monthly treatment for 3 months (4 administrations)
• Placebo
Monthly treatment for 3 months (4 administrations)

Locations

Country	Name	City	State
Netherlands	Department of Vascular Medicine, Academic Medical Center	Amsterdam
Sweden	CTC Clinical Trial Consultants AB	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Athera Biotechnologies AB

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

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