A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Orticumab in Participants with Prior Myocardial Infarction who have Elevated Coronary Inflammation Based on Fat Attenuation Index (FAI) Score Assessed by Coronary Computed Tomography Angiography (CCTA)

Conditions

Atherosclerotic Cardiovascular disease

Brief summary

Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD, LCX), calculated as the average of the analyzable FAI scores (valid baseline and post-baseline FAI score) across the three main coronary arteries, for orticumab compared to placebo after 6 months of treatment

Detailed description

1. Change from baseline for FAI, FAI score (mean absolute change and mean percent change) and FAI score centile for orticumab compared to placebo after 6 months of treatment in the following vessels: o Greatest change in most inflamed vessel o Greatest change in any vessel o RCA only analysis o LAD only analysis o LCX only analysis, 2. Mean absolute change from baseline for mean FAI and mean FAI score, defined as the average of the analyzable vessels (with valid baseline FAI and post-baseline FAI) across the three main coronary arteries (RCA, LAD, LCX), 3. Change from baseline for CaRi-Heart risk score (mean absolute change and mean percent change) for orticumab compared to placebo after 6 months of treatment, 4. Number and percent of participants with treatment-emergent adverse events (TEAEs), and any serious adverse events, 5. Change from baseline in systolic blood pressure, diastolic blood pressure and pulse rate measurements, 6. Change from baseline in clinical safety laboratory parameters, 7. Change from baseline in physical examinations, 8. Serum ADA titers measured at baseline and at specified times over the 6-month treatment period, 9. Serum trough orticumab concentrations following an orticumab dose

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Interventions

DRUGOrticumab

DRUGPlacebo matching orticumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline of the mean Fat Attenuation Index (FAI) score for the 3 coronary arteries (RCA, LAD, LCX), calculated as the average of the analyzable FAI scores (valid baseline and post-baseline FAI score) across the three main coronary arteries, for orticumab compared to placebo after 6 months of treatment	—

Secondary

Measure	Time frame
1. Change from baseline for FAI, FAI score (mean absolute change and mean percent change) and FAI score centile for orticumab compared to placebo after 6 months of treatment in the following vessels: o Greatest change in most inflamed vessel o Greatest change in any vessel o RCA only analysis o LAD only analysis o LCX only analysis, 2. Mean absolute change from baseline for mean FAI and mean FAI score, defined as the average of the analyzable vessels (with valid baseline FAI and post-baseline FAI) across the three main coronary arteries (RCA, LAD, LCX), 3. Change from baseline for CaRi-Heart risk score (mean absolute change and mean percent change) for orticumab compared to placebo after 6 months of treatment, 4. Number and percent of participants with treatment-emergent adverse events (TEAEs), and any serious adverse events, 5. Change from baseline in systolic blood pressure, diastolic blood pressure and pulse rate measurements, 6. Change from baseline in clinical safety laboratory p	—

Measure

Time frame

1. Change from baseline for FAI, FAI score (mean absolute change and mean percent change) and FAI score centile for orticumab compared to placebo after 6 months of treatment in the following vessels: o Greatest change in most inflamed vessel o Greatest change in any vessel o RCA only analysis o LAD only analysis o LCX only analysis, 2. Mean absolute change from baseline for mean FAI and mean FAI score, defined as the average of the analyzable vessels (with valid baseline FAI and post-baseline FAI) across the three main coronary arteries (RCA, LAD, LCX), 3. Change from baseline for CaRi-Heart risk score (mean absolute change and mean percent change) for orticumab compared to placebo after 6 months of treatment, 4. Number and percent of participants with treatment-emergent adverse events (TEAEs), and any serious adverse events, 5. Change from baseline in systolic blood pressure, diastolic blood pressure and pulse rate measurements, 6. Change from baseline in clinical safety laboratory p

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Countries

Czechia, Hungary, Italy, Poland, Romania, Spain, Sweden

Outcome results

None listed