A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease
Coronary Heart Disease
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring DFV890, Phase 2a, coronary heart disease, elevated hsCRP
Eligibility Criteria
Inclusion Criteria: Male and female participants aged between 18 - 80 years (inclusive) at the start of screening will be included. Subjects must have a body mass index (BMI) within the range of 18 - 40 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. Exclusion Criteria: 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. Patients with suspected or proven immunocompromised state at screening History of ongoing, chronic, or major recurrent infectious disease, at the discretion of the investigator, at the start of screening. 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 3 years prior to the start of screening. Symptomatic Class IV heart failure (New York Heart Association) at the start of screening. Planned coronary revascularization (PCI or CABG) or any other major surgical procedure during the study.
Sites / Locations
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Treatment Sequence 1
Treatment sequence 2
Treatment sequence 3
Treatment sequence 4
Participants will be administered Placebo and different doses of DFV890
Participants will be administered Placebo and different doses of DFV890
Participants will be administered different doses of DFV890
Participants will be administered Placebo