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)
NCT ID: NCT06097663
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2024-02-15
2024-11-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study consists of a screening period up to 30 days; a treatment period of approximately 12 weeks with an end of treatment (EOT) visit on Day 85, which is one day after the last dose of DFV890 or placebo; a follow-up period of approximately 1 week; and a standard safety follow-up call approximately 30 days following the last dose. The overall study duration is approximately 21 weeks.
Participants will be randomized to one of five treatment sequences. Based on the treatment sequence assignments, participants will start on either a combination of MAS825 and placebo, DFV890 and placebo, or placebo and placebo on Day 1, and then, within each DFV890 treatment sequence, participants will receive up-titrating doses of DFV890 or placebo at the corresponding study visits.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Sequence 1
Treatment Sequence 1
MAS825
Active MAS825 single dose
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Treatment Sequence 2
Treatment Sequence 2
MAS825 Placebo
MAS825 placebo single dose
DFV890
Oral tablet of DFV890 active once daily
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Treatment Sequence 3
Treatment Sequence 3
MAS825 Placebo
MAS825 placebo single dose
DFV890
Oral tablet of DFV890 active once daily
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Treatment Sequence 4
Treatment Sequence 4
MAS825 Placebo
MAS825 placebo single dose
DFV890
Oral tablet of DFV890 active once daily
Treatment Sequence 5
Treatment Sequence 5
MAS825 Placebo
MAS825 placebo single dose
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MAS825
Active MAS825 single dose
MAS825 Placebo
MAS825 placebo single dose
DFV890
Oral tablet of DFV890 active once daily
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Patients with suspected or proven immunocompromised state at 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.
* Planned coronary revascularization (percutaneous coronary intervention (PCI) or CABG) or any other major surgical procedure during the study (until End of Study (EOS)).
* Symptomatic Class IV heart failure (New York Heart Association \[NYHA\]) at the start of screening.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University
St Louis, Missouri, United States
Vanderbilt University Medical Cent
Nashville, Tennessee, United States
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
München, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sumida K, Obeng EA, Kovesdy CP. Clonal Hematopoiesis in Kidney Disease. Clin J Am Soc Nephrol. 2025 Sep 11. doi: 10.2215/CJN.0000000895. Online ahead of print. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-506741-34-00
Identifier Type: OTHER
Identifier Source: secondary_id
CADPT15A12201
Identifier Type: -
Identifier Source: org_study_id