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Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

This study is currently recruiting participants.
Verified October 2017 by Athera Biotechnologies AB
Sponsor:
ClinicalTrials.gov Identifier:
NCT03320265
First Posted: October 25, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Athera Biotechnologies AB
  Purpose

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 Intervention Phase
Arterial Inflammation Cardiovascular Diseases Drug: PC-mAb Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Athera Biotechnologies AB:

Primary Outcome Measures:
  • Monocyte function [ Time Frame: From baseline (Day 1) to visit 11 (Day 85) ]
    Change in transendothelial migration (TEM) in monocytes isolated from treated subjects


Secondary Outcome Measures:
  • Arterial inflammation [ Time Frame: 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)

  • Arterial stiffness [ Time Frame: From baseline (Day 1) to visit 11 (Day 85) ]
    Change in pulse wave velocity (PWV) (m/sec)

  • Adverse events (AEs)/serious AEs (SAEs) [ Time Frame: From baseline (Day 1) to visit 11 (Day 85) ]
    Incidence of AEs/SAEs

  • Vital signs, height [ Time Frame: At screening (Day -63 to -1) ]
    in cm

  • Vital signs, body weight [ Time Frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) ]
    in kg

  • Vital signs, blood pressure [ Time Frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) ]
    in mmHg

  • Vital signs, hear rate [ Time Frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) ]
    in bpm

  • Vital signs, body temperature [ Time Frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143) ]
    in °C

  • Physical examination including review of all organ systems [ Time Frame: 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

  • Electrocardiogram (ECG), PR (PQ) [ Time Frame: 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

  • ECG, QRS [ Time Frame: 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

  • ECG, QT [ Time Frame: 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

  • ECG, QTcF [ Time Frame: 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


Estimated Enrollment: 40
Actual Study Start Date: October 11, 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320265


Contacts
Contact: Carina Schmidt +46 (0)761 938 190 c.schmidt@athera.se

Locations
Netherlands
Department of Vascular Medicine, Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Eric SG Stroes, MD, Prof.         
Sweden
CTC Clinical Trial Consultants AB Recruiting
Uppsala, Sweden, 75237
Contact: Folke Sjöberg, MD, Prof.         
Sponsors and Collaborators
Athera Biotechnologies AB
Investigators
Principal Investigator: Eric SG Stroes, MD, Prof. Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
  More Information

Responsible Party: Athera Biotechnologies AB
ClinicalTrials.gov Identifier: NCT03320265     History of Changes
Other Study ID Numbers: ATH3G10-005
First Submitted: October 10, 2017
First Posted: October 25, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017

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:
Inflammation
Cardiovascular Diseases
Arteritis
Pathologic Processes
Vasculitis
Vascular Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs