Arterial InflammationPhase 2NCT03320265
Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a
A Phase 2 study testing PC-mAb in people with Arterial Inflammation and Cardiovascular Diseases, run by Athera Biotechnologies AB at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arterial Inflammation, Cardiovascular Diseases
- What is being tested?
- PC-mAb
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Oct 2017to 3 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Department of Vascular Medicine, Academic Medical Center
Amsterdam, 1105 AZ
About this study
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
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).
- Conditions
- Arterial Inflammation, Cardiovascular Diseases
- Being tested
- PC-mAb, Placebo
- Keywords
- Phosphorylcholine human monoclonal antibody, Lipoprotein a
- Medical subject headings
- Arteritis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-mAbDrug
Monthly treatment for 3 months (4 administrations)
PlaceboDrug
Monthly treatment for 3 months (4 administrations)
| Study group | Role | What they receive |
|---|---|---|
| PC-mAb | Experimental | Phosphorylcholine human monoclonal antibody, i.v. infusions Receives: Drug: PC-mAb |
| Placebo | Placebo comparator | Placebo to PC-mAb, i.v. infusions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte function
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
Measured: From baseline (Day 1) to visit 11 (Day 85)
Secondary outcomes (13)
Arterial inflammation
Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (FDG-PET/CT)
Measured: From baseline (Day 1) to visit 11 (Day 85)
Arterial stiffness
Change in pulse wave velocity (PWV) (m/sec)
Measured: From baseline (Day 1) to visit 11 (Day 85)
Adverse events (AEs)/serious AEs (SAEs)
Incidence of AEs/SAEs
Measured: From baseline (Day 1) to visit 11 (Day 85)
Vital signs, height
in cm
Measured: At screening (Day -63 to -1)
Vital signs, body weight
in kg
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start11 Oct 2017
- Primary completion19 Mar 2018
- Study completion3 Jul 2018
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athera Biotechnologies AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric SG Stroes, MD, Prof., Principal investigator, Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320265
- Sponsor's protocol ID
- ATH3G10-005
- Status last verified
- Jul 2018
- First submitted
- 10 Oct 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320265
- Acronym / sponsor ID
- ATH3G10-005
- Conditions
- Arterial Inflammation, Cardiovascular Diseases
- Keywords
- Phosphorylcholine human monoclonal antibody, Lipoprotein a
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Athera Biotechnologies ABIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC-mAb | Experimental | Drug: PC-mAbPhosphorylcholine human monoclonal antibody, i.v. infusions |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to PC-mAb, i.v. infusions |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-mAbMonthly treatment for 3 months (4 administrations) | Drug | PC-mAb |
| PlaceboMonthly treatment for 3 months (4 administrations) | Drug | Placebo |
Primary outcome
Monocyte function
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Change in transendothelial migration (TEM) in monocytes isolated from treated subjects
13 secondary outcomes
Arterial inflammation
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Arterial stiffness
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Adverse events (AEs)/serious AEs (SAEs)
Time frame: From baseline (Day 1) to visit 11 (Day 85)
Vital signs, height
Time frame: At screening (Day -63 to -1)
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)
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)
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)
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)
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)
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)
ECG, QRS
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QT
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
ECG, QTcF
Time frame: At screening (Day -63 to -1), Day 1, Day 28, Day 56, Day 84 and end of study (Day 143)
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SG Stroes, MD, Prof. principal investigator
Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PC-mAb in people with Arterial Inflammation and Cardiovascular Diseases, run by Athera Biotechnologies AB at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte function (time frame: From baseline (Day 1) to visit 11 (Day 85)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.