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Atherosclerotic Cardiovascular DiseasePhase 2NCT02388971

Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease

A Phase 2 study testing MLN1202 in people with Atherosclerotic Cardiovascular Disease, run by Takeda.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Atherosclerotic Cardiovascular Disease
What is being tested?
MLN1202
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2016to Apr 2016
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form (including consent for pharmacogenomics [PGx] collection) and any required privacy authorization prior to the initiation of any study procedures.
  • Is male or female and aged 35 to 80 years, inclusive at Screening.
  • Has documented atherosclerotic vascular disease (eg, coronary artery disease (CAD), peripheral arterial disease, aortic atherosclerosis or abdominal aortic aneurysm (<5 cm), carotid disease, or cerebrovascular disease) and has been clinically stable for at least 3 months prior to Screening. Documentation sufficient to demonstrate presence of atherosclerotic vascular disease will include one or more of the following:
  • i. History of myocardial infarction.
  • ii. History of stroke.
  • iii. Framingham score indicating >20% 10-year risk in an individual who is age >55.
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  • iv. Documentation of atherosclerotic disease by objective diagnostic testing.
  • Are willing to undergo 2, 2-deoxy-2-[^18F]-fluoro-D-g1ucose positron emission tomography (FDG PET)/CT scans, have a body weight compatible with their imaging center's PET/CT scanner table limits and be able to tolerate the imaging procedure.
  • Are statin naïve or are taking a stable statin dose AND, if taking a statin, are not on a high dose of a high-potency statin. A high-dose of high potency statin is defined as atorvastatin ≥40 mg/day or rosuvastatin ≥20 mg/day. Furthermore, statin dose must be stable for at least 6 weeks prior to Screening FDG PET /CT scan and must not be changed during the remainder of the study.

Who cannot join

  • Has a history or clinical manifestations of:
  • a) Type 1 diabetes mellitus.
  • b) Significant heart failure (eg, New York Heart Association class III or IV).
  • c) Active or chronic liver disease.
  • d) Any chronic systemic inflammatory condition requiring ongoing therapy with anti-inflammatory drugs.
  • e) Any history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1 of this study.
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  • f) Any infection requiring antibiotic therapy within 6 weeks prior to Screening FDG PET/CT.
  • g) Any acute infection within 2 weeks of Screening FDG PET/CT scan.
  • h) Impaired renal function (estimated creatinine clearance <60 ml/min as calculated by the Cockcroft Gault formula). Re-testing may be allowed on a case by case basis.
  • Requires ongoing therapy with any systemic anti-inflammatory drugs (except nonsteroidal anti-inflammatory drug [NSAIDs]), including systemic anti-inflammatory steroids, methotrexate, colchicine, anti-inflammatory biologics, or any other compound that in the opinion of the investigator has a substantial anti-inflammatory effect.
  • Has received treatment with systemic immunosuppressant or systemic anti- inflammatory medications within 6 weeks prior to Screening FDG PET/CT scan.
  • Has a history of hypersensitivity or allergies to any component of the study medication or history of hypersensitivity to monoclonal antibodies.
  • Has any significant medical condition(s) which, in the investigator's opinion, may interfere with the participant's optimal participation in the study.
  • Has poorly controlled blood glucose, defined for the purposes of this study as glycosylated hemoglobin (HbA1c) ≥7.75% at Screening.
  • Screening FDG PET/CT scan has inadequate vascular uptake (target to background ratio [TBR] <1.6) in all of the index vessels (ascending aorta, left carotid, right carotid) as assessed by the imaging core laboratory.

About this study

Official title: A Randomized, Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PET/CT Imaging

The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.

Read the detailed description

The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat people who have stable atherosclerotic cardiovascular disease (CVD). This study will look at changes in arterial inflammation in people who take MLN1202 in addition to standard-of-care (SOC) therapy.

The study will enroll approximately 108 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • MLN1202 Dose A intravenously (IV)
  • Placebo (dummy inactive solution) - this is a solution that looks like the study drug but has no active ingredient

All participants will receive IV administration of MLN1202 or placebo on Day 1, Day 29, and Day 57 of this study.

This multi-centre trial will be conducted in the United States. The overall time to participate in this study is 19 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone approximately 35 days after last dose of study drug for a follow-up assessment.

Being tested
MLN1202, Placebo
Keywords
Drug therapy
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MLN1202Drug

    MLN1202 solution

  • PlaceboDrug

    MLN1202 placebo-matching solution

Study groups in NCT02388971
Study groupRoleWhat they receive
MLN1202 DoseExperimentalMLN1202 Dose, intravenously (IV), once on Days 1, 29 and 57.
Receives: Drug: MLN1202
MLN1202 PlaceboExperimentalMLN1202 placebo, intravenously (IV), once on Days 1, 29 and 57.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points

    The primary imaging endpoint of interest is the FDG uptake, measured as a target to background ratio (TBR) within the most diseased segment (MDS) of the index vessel.

    Measured: Baseline and 3 month post-treatment

Secondary outcomes (5)

  1. The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points in subjects identified using a dominant model of the snip in the MCP-1 polymorphisms [MCP-1 -2518 (rs1024611)].

    Measured: Baseline and 3 month post-treatment

  2. Change from Baseline in Mean Carotid Vessel MDS TBR

    Average mean of the maximum TBR in the MDS of the combined right and left carotid artery walls will be measured using 2-deoxy-2-[18F]-fluoro-D-g1ucose positron emission tomography/computed tomography (FDG PET/CT).

    Measured: Baseline and Day 82

  3. Change from Baseline in Mean Active Segment TBR

    TBR will be measured in both ascending aorta and carotids with demonstrable inflammation at Baseline using FDG PET/CT.

    Measured: Baseline and Day 82

  4. Change from Baseline in Mean Index Vessel TBR

    FDG uptake in the artery wall within the entire index vessel will be measured using FDG PET/CT.

    Measured: Baseline and Day 82

  5. Change from Baseline in Mean Carotid Vessel TBR

    The average mean of the maximum TBR and the MDS of the combined right and left carotid artery walls will be measured using FDG PET/CT.

    Measured: Baseline and Day 82

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2016 (estimated)
  4. Study completionApr 2016 (estimated)

Why it stopped: Study has withdrawn.

Resources

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, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388971
Sponsor's protocol ID
MLN1202-2006
Other IDs
U1111-1159-5742
Status last verified
Dec 2015
First submitted
23 Feb 2015
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MLN1202 in people with Atherosclerotic Cardiovascular Disease, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 withdrawn before enrolling participants, so there are no results.

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?

The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points (time frame: Baseline and 3 month post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02388971.

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 10 Dec 2015.

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