NCT06097663CompletedPhase 2
A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)
A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in an Adult Population With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)
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, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (variant allele frequency \[VAF\] ≥2%).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 18 Oct 2023
- Start date
- 15 Feb 2024
- Primary completion date
- 27 Oct 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Coronary artery disease
- NCT number
- NCT06097663
- EU CT number
- 2023-506741-34-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 15 Feb 2024 to the primary completion date, 27 Oct 2024
- 6 sites in 3 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 3 years prior to the start of screening.
- Planned coronary revascularization (percutaneous coronary intervention (PCI) or CABG) or any other major surgical procedure during the study (until End of Study (EOS)).
Other illness
- At screening, pre-malignant clonal cytopenias or clonal cytopenia of unknown significance (CCUS).
- 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 \[NYHA\]) 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 - 80 years (inclusive) at the start of screening will be included.
- Participants must have a body mass index (BMI) within the range of 18 - 40 kg/m2 at screening. 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 (Thygesen et al 2007).
- Known presence of CHIP, restricted to driver mutations in TET2 or DNMT3A with a VAF ≥2%, as documented in the participant's medical history.
- 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 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
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 |
| - Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| - Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Vanderbilt University Medical Cent Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.