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Recruiting NCT07448038

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

Phase II Interventional Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selnoflast, Placebo.
Who it may be relevant to
Registry conditions: Atherosclerosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • 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]) [Time frame: Baseline up to Week 12]
Secondary outcome measures (7)
  • Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L) [Time frame: 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) [Time frame: Baseline and Week 12]
  • Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: Up to approximately 20 weeks]
  • Plasma Concentration of Selnoflast at Specified Timepoints [Time frame: Up to 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 15 centers
  • 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
  • … and 7 more centers
Canada · 1 center
  • Cardio Health Clinical Trials — Hamilton

Identifiers

NCT: NCT07448038 · GC46102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗