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

Purpose

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.

Condition

  • Atherosclerosis

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selnoflast 		Participants will receive selnoflast, orally (PO), twice a day (BID) for 12 weeks.
  • Drug: Selnoflast
    Selnoflast will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO7486967
Placebo Comparator
Placebo 		Participants will receive placebo, PO, BID for 12 weeks.
  • Drug: Placebo
    Placebo will be administered as per the schedule specified in the respective arm.

Recruiting Locations

Cardiovascular Research Foundation of Southern California
Beverly Hills, California 90210

Alliance Clinical West Hills (Focus Clinical Research)
West Hills, California 91307

Asha Clinical Research-Munster,Llc
Hammond, Indiana 46324

Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15243

Eastside Research Associates, LLC dba Era Health Research
Redmond, Washington 98036

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GC46102 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com