A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

Korábbi kezelés

• Patients receiving concomitant medications that are known to be strong or moderate inducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, strong inhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatment cannot be discontinued or switched to a different medication within 5 half-lives or 1 week (whichever is longer) prior to Day 1 and for the duration of the study.
• Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
• Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 6 months prior to the start of screening.
• Planned coronary revascularization (PCI or CABG) or any other major surgical procedure during the study.

Más betegség

• History of ongoing, chronic, or major recurrent infectious disease, at the discretion of the investigator, at the start of screening.
• Symptomatic Class IV heart failure (New York Heart Association) at the start of screening.

Egyéb

• Patients with suspected or proven immunocompromised state at screening

• Male and female participants aged between 18 - 85 years (inclusive) at the start of screening will be included.
• Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI = Body weight (kg) / [Height (m)]2
• Documented spontaneous myocardial infarction (MI) (diagnosed according to the universal MI criteria with or without evidence of ST segment elevation) at least 30 days before the start of screening.
• Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening. Screening values must be separated by a minimum of 8 days. The initial hsCRP value must be a minimum of 30 days after the qualifying MI or after any percutaneous coronary intervention (PCI) performed separately from the qualifying MI.
• For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically indicated, participants must be on a stable regimen (at least 4 weeks before randomization), with no planned statin dose changes over the course of the trial treatment period. Unplanned statin dose changes during the trial treatment period may occur.