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Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Sponsor
Athera Biotechnologies AB (Industry)
Overall Status
Terminated
CT.gov ID
NCT03320265
Collaborator
(none)
10
Enrollment
2
Locations
2
Arms
8.7
Actual Duration (Months)
5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 11, 2017
Actual Primary Completion Date :
Mar 19, 2018
Actual Study Completion Date :
Jul 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: PC-mAb

Phosphorylcholine human monoclonal antibody, i.v. infusions

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

Placebo to PC-mAb, i.v. infusions

Drug: Placebo
Monthly treatment for 3 months (4 administrations)

Outcome Measures

Primary Outcome Measures

  1. Monocyte function [From baseline (Day 1) to visit 11 (Day 85)]

    Change in transendothelial migration (TEM) in monocytes isolated from treated subjects

Secondary Outcome Measures

  1. Arterial inflammation [From baseline (Day 1) to visit 11 (Day 85)]

    Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)

  2. Arterial stiffness [From baseline (Day 1) to visit 11 (Day 85)]

    Change in pulse wave velocity (PWV) (m/sec)

  3. Adverse events (AEs)/serious AEs (SAEs) [From baseline (Day 1) to visit 11 (Day 85)]

    Incidence of AEs/SAEs

  4. Vital signs, height [At screening (Day -63 to -1)]

    in cm

  5. Vital signs, body weight [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    in kg

  6. Vital signs, blood pressure [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    in mmHg

  7. Vital signs, hear rate [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    in bpm

  8. Vital signs, body temperature [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    in °C

  9. Physical examination including review of all organ systems [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    Any abnormalities will be recorded

  10. Electrocardiogram (ECG), PR (PQ) [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    12-lead ECG; PR (PQ) interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

  11. ECG, QRS [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    12-lead ECG; QRS interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

  12. ECG, QT [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    12-lead ECG; QT interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

  13. ECG, QTcF [At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)]

    12-lead ECG; QTcF interval (in msec) will be measured and reported descriptively; any abnormalities will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Vascular Medicine, Academic Medical Center Amsterdam Netherlands 1105 AZ
2 CTC Clinical Trial Consultants AB Uppsala Sweden 75237

Sponsors and Collaborators

  • Athera Biotechnologies AB

Investigators

  • Principal Investigator: Eric SG Stroes, MD, Prof., Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Athera Biotechnologies AB
ClinicalTrials.gov Identifier:
NCT03320265
Other Study ID Numbers:
  • ATH3G10-005
First Posted:
Oct 25, 2017
Last Update Posted:
Jul 6, 2018
Last Verified:
Jul 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Athera Biotechnologies AB
Phosphorylcholine human monoclonal antibody
Lipoprotein a
Additional relevant MeSH terms:
Cardiovascular Diseases
Arteritis
Inflammation

Study Results

No Results Posted as of Jul 6, 2018