Study Stopped
Terminated
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
1 other identifier
interventional
10
2 countries
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2017
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2018
CompletedJuly 6, 2018
July 1, 2018
5 months
October 10, 2017
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Monocyte function
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
From baseline (Day 1) to visit 11 (Day 85)
Secondary Outcomes (13)
Arterial inflammation
From baseline (Day 1) to visit 11 (Day 85)
Arterial stiffness
From baseline (Day 1) to visit 11 (Day 85)
Adverse events (AEs)/serious AEs (SAEs)
From baseline (Day 1) to visit 11 (Day 85)
Vital signs, height
At screening (Day -63 to -1)
Vital signs, body weight
At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
- +8 more secondary outcomes
Study Arms (2)
PC-mAb
EXPERIMENTALPhosphorylcholine human monoclonal antibody, i.v. infusions
Placebo
PLACEBO COMPARATORPlacebo to PC-mAb, i.v. infusions
Interventions
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Vascular Medicine, Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
CTC Clinical Trial Consultants AB
Uppsala, 75237, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric SG Stroes, MD, Prof.
Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 25, 2017
Study Start
October 11, 2017
Primary Completion
March 19, 2018
Study Completion
July 3, 2018
Last Updated
July 6, 2018
Record last verified: 2018-07