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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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.
Time frame: Baseline and 3 month post-treatment
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)].
Time frame: Baseline and 3 month post-treatment
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).
Time frame: Baseline and Day 82
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.
Time frame: Baseline and Day 82
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.
Time frame: Baseline and Day 82
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.
Time frame: Baseline and Day 82
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