Coronary artery disease Circulatory System
Conditions
Interventions
The participants in the parent study and sub-study will be divided in the following two treatment arms:
1. Selnoflast: Participants will receive selnoflast capsules, orally, twice daily (BID), from Da
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and over at the time of signing Informed Consent Form 2. A diagnosis of stable CAD with a history of myocardial infarction (MI) (known or suspected to be atherothrombotic Type 1) at least 90 days prior to screening Visit 1. Sub-study participants may have coronary revascularization at least 90 days prior to screening visit 1 and within 10 years of screening visit 1 3. Elevated plasma hsCRP level of = 2 mg/l at screening visit 1 and 2 4. QTcF = 450 ms in men and = 470 ms in women by a single 12-lead ECG recording 5. Participants with CAD, pathogenic TET2 mutation(s) indicating a variant allele frequency (VAF) > 2% indicative of CHIP, and elevated hsCRP will be enrolled in the sub-study
Exclusion criteria
Exclusion criteria: 1. Individuals with Class III and IV heart failure According to New York Heart Association 2. Planned procedure or surgery during the study and any major surgery within 90 days prior to screening Visit 1 3. Treatment with a live, attenuated vaccine within 90 days prior to the randomization visit 4. Treatment with a COVID-19 vaccine (including boosters) or other non-live vaccines (e.g., flu) within 28 days prior to the randomization visit 5. Current treatment with medications that are well known to prolong the QT interval or a known history of long QT syndrome or torsade de pointes 6. Positive hepatitis C virus (HCV) antibody test and subsequent positive HCV RNA test at screening 7. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test at screening 8. Positive human immunodeficiency virus (HIV) tests (HIV-1 antibody, HIV-1/2 antibody, HIV-2 antibody) at screening 9. History of tuberculosis or a positive interferon-? (IFN-?) release test at screening 10. Uncontrolled hypertension, defined as an average systolic blood pressure > 160 mmHg or an average diastolic blood pressure > 100 mmHg at each screening visit 11. Prior malignancy other than basal cell skin carcinoma, fully excised squamous cell carcinoma, and cervical intraepithelial neoplasia 12. Poor peripheral venous access 13. Uncontrolled cardiac arrhythmia, defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with adverse events (AEs) measured from screening up to 28 days after the final dose of study drug (up to day 56) 2. Percentage of participants with severity of AEs determined according to the National Cancer Institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0) grading scale measured from screening up to 28 days after the final dose of study drug (up to day 56) 3. Percentage of participants with clinically significant changes in vital sign values measured using respiratory rate, pulse rate, systolic and diastolic blood pressure and temperature measured from screening up to 28 days after the final dose of study drug (up to day 56) 4. Percentage of participants with clinically significant abnormalities in electrocardiogram (ECG) parameters Measured Using Single 12-Lead ECG from screening up to 28 days after the final dose of study drug (up to day 56) 5. Percentage of participants with clinically significant laboratory findings measured using blood and urine samples from screening up to 28 days after the final dose of study drug (up to day 56) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of selnoflast and its metabolites, if applicable, measured using plasma samples collected at specified timepoints (pre-dose and post-dose) from day 1 to day 29 2. Change From baseline in hsCRP measured using blood samples collected at specified timepoints from screening up to 28 days after the final dose of study drug (up to day 56) | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed