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Anti-inflammatory Agent

DFV890 + MAS825 for Coronary Heart Disease

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For participants on statin therapy, participants must be on a stable regimen with no planned statin dose changes over the course of the trial treatment period
Known presence of CHIP, restricted to driver mutations in TET2 or DNMT3A with a VAF ≥2%
Must not have
Multi-vessel coronary artery bypass graft (CABG) surgery within the past 3 years prior to the start of screening
Use of any biologic drugs targeting the immune system within 26 weeks of Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 22 to day 92

Summary

This trial will test the safety and effectiveness of increasing doses of a daily oral medication called DFV890 for 12 weeks in 28 people with coronary heart disease and specific genetic mutations. The goal is

Who is the study for?
Adults aged 18-80 with coronary heart disease and a specific genetic change called CHIP are eligible for this trial. They must have had a heart attack at least 30 days prior to screening and be on a stable statin regimen if applicable. Their BMI should be between 18 - 40 kg/m2.
What is being tested?
The trial is testing DFV890, an oral medication taken daily for 12 weeks, and MAS825, given as a single shot, against placebos to see if they can lower inflammation markers in the blood that are linked to cardiovascular disease risk.
What are the potential side effects?
While not specified here, common side effects of drugs like DFV890 and MAS825 may include reactions at the injection site for MAS825 or gastrointestinal issues, headaches, or fatigue for DFV890.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable statin regimen with no changes expected during the trial.
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I have specific genetic mutations in my blood cells.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had heart bypass surgery in the last 3 years.
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I haven't taken immune-targeting biologic drugs in the last 6 months.
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I am scheduled for a major surgery, such as heart surgery, during the study.
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I have a long-term or frequently returning infection.
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I have severe heart failure symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 22 to day 92
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 22 to day 92 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum level of IL-6
Serum levels of IL-6 and IL-18
Secondary study objectives
Plasma trough concentrations (Ctrough) of DFV890 at steady-state
Serum concentrations of MAS825 after a single s.c. dose of MAS825

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Sequence 4Experimental Treatment2 Interventions
Treatment Sequence 4
Group II: Treatment Sequence 3Experimental Treatment3 Interventions
Treatment Sequence 3
Group III: Treatment Sequence 2Experimental Treatment3 Interventions
Treatment Sequence 2
Group IV: Treatment Sequence 1Experimental Treatment2 Interventions
Treatment Sequence 1
Group V: Treatment Sequence 5Placebo Group2 Interventions
Treatment Sequence 5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAS825
2019
Completed Phase 3
~230
DFV890
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,624 Total Patients Enrolled
~18 spots leftby Nov 2025
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