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

Официальное название

A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Selnoflast in Reducing Vascular Inflammation in Patients With Atherosclerosis at Risk for Major Adverse Cardiac Events

Обзор

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.

Вмешательства

• Препарат Selnoflast
  Selnoflast will be administered as per the schedule specified in the respective arm.
• Препарат Placebo
  Placebo will be administered as per the schedule specified in the respective arm.

Первичные конечные точки

• Change in mdsTBR (Most-diseased Segment TBR [Target-to-background Ratio]) of Index Vessel From Baseline to Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 milligrams per liter [mg/L]) [Срок оценки: Baseline up to Week 12]

Вторичные конечные точки (7)

• Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L) [Срок оценки: Baseline and Week 12]
• Change From Baseline in mdsTBR of Carotids at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L) [Срок оценки: Baseline and Week 12]
• Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) [Срок оценки: Baseline and Week 12]
• Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2 mg/L) [Срок оценки: Baseline and Week 12]
• Change From Baseline in Active Segments TBR and the Whole Vessel TBR of the Index Vessel at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) [Срок оценки: Baseline and Week 12]
• Number of Participants With Adverse Events (AEs) and Severity of AEs Determined According to the NCI CTCAE v5.0 Grading Scale [Срок оценки: Up to approximately 20 weeks]
• Plasma Concentration of Selnoflast at Specified Timepoints [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Cardiovascular Research Foundation of Southern California — Beverly Hills
• National Heart Institute — Beverly Hills
• Amnova Clinical Research — Irvine
• Alliance Clinical West Hills (Focus Clinical Research) — West Hills
• Inpatient Research Clinic (Las Palmas Medical Research Center) — Miami Lakes
• Asha Clinical Research-Munster,Llc — Hammond
• Profound Research LLC at Cardiology and Vascular Associates - CAVA — Bloomfield Hills
• Profound Research LLC at Millenium Cardiology — Farmington Hills
• … и ещё 7 центров

Канада · 1 центр

• Cardio Health Clinical Trials — Hamilton

Идентификаторы

NCT: NCT07448038 · GC46102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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