Overview
The main purpose of the study is to evaluate the efficacy of selnoflast compared with placebo in participants with atherosclerosis, at high-risk for major adverse cardiovascular event (MACE), who are currently on standard-of-care (SOC) therapy.
Eligibility
Inclusion Criteria:
- Confirmed evidence of atherosclerosis
- Left or right carotid TBR ≥ 1.8 or aorta TBR ≥ 2.0 on centrally-assessed 18F-fluorodeoxyglucose-Positron Emission Tomography (18F-FDG-PET) scan
- Stable treatment of atherosclerosis through the use of SOC medications or revascularization
- QT interval corrected through use of Fridericia's formula (QTcF) of ≤ 450 milliseconds (ms) in men and ≤ 470 ms in women by a single 12-lead electrocardiogram (ECG) recording
Exclusion Criteria:
- Individuals with Class III and IV heart failure
- Uncontrolled cardiac arrhythmia
- Uncontrolled hypertension
- Suspected or known immunocompromised state
- Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1
- History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- Positive test results for hepatitis B (HBV) infection at screening
- Positive hepatitis C virus (HCV) antibody test at screening
- Positive human immunodeficiency virus (HIV) test at screening
- Treatment with any live vaccine within 28 days prior to the first dose of study drug until the end of the study
- Treatment with other non-live vaccines within 14 days prior to the first dose of study drug until the end of the study
