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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
162
Selnoflast will be administered as per the schedule specified in the respective arm.
Placebo will be administered as per the schedule specified in the respective arm.
Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California, United States
RECRUITINGChange 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])
hsCRP=high-sensitivity C-reactive protein.
Time frame: Baseline up to Week 12
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
NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0.
Time frame: Up to approximately 20 weeks
Plasma Concentration of Selnoflast at Specified Timepoints
Reference Study ID Number: GC46102 https://forpatients.roche.com/
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Time frame: Up to 12 weeks