A Phase 2 interventional study of PC-mAb and Placebo in Arterial Inflammation and Cardiovascular Diseases, sponsored by Athera Biotechnologies AB. Terminated at 2 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Athera Biotechnologies AB · Phase 2, Interventional, and Treatment
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).
20 studies on the registry are indexed under Arteritis; 3 are open to participants now.
This study's enrollment of 10 is below the median of 64 across 12 interventional studies indexed under Arteritis.
Browse Arteritis studies →Athera Biotechnologies AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major inclusion criterion:
Major exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phosphorylcholine human monoclonal antibody, i.v. infusions
Drug: PC-mAb
Placebo to PC-mAb, i.v. infusions
Drug: Placebo
Monthly treatment for 3 months (4 administrations)
Monthly treatment for 3 months (4 administrations)
Monocyte function
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Arterial inflammation
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)
Arterial stiffness
Change in pulse wave velocity (PWV) (m/sec)
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Adverse events (AEs)/serious AEs (SAEs)
Incidence of AEs/SAEs
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Vital signs, height
in cm
Time frame: At screening (Day -63 to -1)
Vital signs, body weight
in kg
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, blood pressure
in mmHg
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, hear rate
in bpm
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Vital signs, body temperature
in °C
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Physical examination including review of all organ systems
Any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Electrocardiogram (ECG), PR (PQ)
12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QRS
12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QT
12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QTcF
12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Athera Biotechnologies AB