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Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

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ClinicalTrials.gov Identifier: NCT03320265
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Athera Biotechnologies AB

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : October 11, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

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)




Primary Outcome Measures :
  1. 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 :
  1. 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)

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

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

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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Athera Biotechnologies AB
ClinicalTrials.gov Identifier: NCT03320265     History of Changes
Other Study ID Numbers: ATH3G10-005
First Posted: October 25, 2017    Key Record Dates
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