Atherosclerosis
Conditions
Brief summary
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
DRUGSelnoflast
Selnoflast will be administered as per the schedule specified in the respective arm.
DRUGPlacebo
Placebo will be administered as per the schedule specified in the respective arm.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Estimated glomerular filtration rate \<50 mL/min/1.73 m² 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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]) | Baseline up to Week 12 | hsCRP=high-sensitivity C-reactive protein. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of Selnoflast at Specified Timepoints | Up to 12 weeks | — |
| Change From Baseline in mdsTBR of Index Vessel at Week 12 in all Participants (hsCRP < 2 mg/L and ≥ 2mg/L) | 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) | Baseline and Week 12 | — |
| Change From Baseline in mdsTBR of Carotids at Week 12 in Participants With Baseline Elevated hsCRP (≥ 2 mg/L) | 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) | 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 | Up to approximately 22 weeks | NCI CTCAE v5.0 = National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 5.0. |
| 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) | Baseline and Week 12 | — |
Countries
Canada, United States
Contacts
CONTACTReference Study ID Number: GC46102 https://forpatients.roche.com/
CONTACTFastest response: use the inquiry form. No email attachments https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed