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A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vascular Inflammation in Participants With Atherosclerosis at Risk for Major Adverse Cardiac Events

RecruitingPhase 2Ages 18 Years - anyAllGenentech, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Confirmed evidence of atherosclerosis * Left or right carotid TBR โ‰ฅ 1.8 or aorta TBR โ‰ฅ 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 โ‰ค 450 milliseconds (ms) in men and โ‰ค 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 * Estimated glomerular filtration rate \<50 mL/min/1.73 mยฒ as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation, at the time of 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
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What it tests

  • Selnoflast
  • Placebo
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Where

25 sites
Cardiovascular Research Foundation of Southern California
Beverly Hills, United States
National Heart Institute
Beverly Hills, United States
Amnova Clinical Research
Irvine, United States
UCLA Health System - UCLA Cardiovascular Center
Los Angeles, United States
NorthBay Clinical Research
Santa Rosa, United States
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, United States
Yale University School of Medicine Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
New Haven, United States
Inpatient Research Clinic (Las Palmas Medical Research Center)
Miami Lakes, United States

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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