Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key marker...
Detailed Description
This is a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study to evaluate the efficacy, safety, and tolerability of intra-individual dose escalation of DFV890 for...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 6 months 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.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06031844
Start Date
October 16 2023
End Date
December 23 2024
Last Update
September 15 2025
Active Locations (7)
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1
Valley Clinical Trials
Northridge, California, United States, 91325
2
Excel Medical Clinical Trials LLC
Boca Raton, Florida, United States, 33434
3
UF Health Science Center
Jacksonville, Florida, United States, 32209
4
Triad Clinical Trials LLC
Greensboro, North Carolina, United States, 27410