NCT06031844CompletedPhase 2
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
A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
This Phase 2a clinical trial evaluated the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 24 people with known heart disease and an elevated marker of inflammation, hsCRP.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 4 Sept 2023
- Start date
- 16 Oct 2023
- Primary completion date
- 17 Dec 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Coronary artery disease
- NCT number
- NCT06031844
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 24
- From 16 Oct 2023 to the primary completion date, 17 Dec 2024
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Patients with suspected or proven immunocompromised state at screening
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Excel Medical Clinical Trials, LLC Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Triad Clinical Trials, LLC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| UF Health Science Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| Monument Health Clinical Research Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Universal Research Group LLC Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.