Not recruiting

Study on DFV890 and MAS825 for Reducing Inflammation in Adults with Coronary Heart Disease and Clonal Hematopoiesis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two treatments, DFV890 and MAS825, in people with coronary heart disease and a condition known as Clonal Hematopoiesis of Indeterminate Potential (CHIP). Coronary heart disease is a condition where the blood vessels supplying the heart become narrowed or blocked, which can lead to heart attacks. CHIP is a condition where certain blood cells have genetic changes that might increase the risk of heart disease. The purpose of this study is to see if these treatments can help reduce inflammation in the body, which is often linked to these conditions.

The study will involve taking either the treatment or a placebo, which looks like the treatment but does not contain the active medicine. DFV890 is taken as a film-coated tablet, while MAS825 is given as a concentrate for infusion, which means it is administered through a needle under the skin. Participants will be randomly assigned to different groups to receive either the treatment or the placebo. The study will last for a period of up to 84 days, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, participants will have their blood tested to measure levels of certain inflammatory markers, which are substances in the blood that can indicate inflammation. The study will also monitor for any side effects or changes in health, including vital signs like blood pressure and heart rate, as well as conducting tests like electrocardiograms (ECGs) to check heart function. The goal is to understand how well the treatments work and how safe they are for people with coronary heart disease and CHIP.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and initial assessment
Upon joining the study, participants are randomly assigned to different groups. This process is called randomization and ensures that each participant has an equal chance of receiving either the study medication or a placebo.
An initial assessment is conducted to gather baseline data. This includes measuring vital signs, conducting electrocardiograms (ECGs), and collecting blood and urine samples for laboratory assessments.
Step 2
Medication administration
Participants receive either the study medication or a placebo. The study medication includes DFV890 and MAS825.
DFV890 is administered orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.
MAS825 is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is determined by the study protocol.
Step 3
Monitoring and follow-up
Participants are monitored for any adverse events or side effects. This includes regular check-ups to assess vital signs, ECGs, and laboratory tests.
Blood samples are taken to measure serum levels of specific markers, such as IL-6 and IL-18, at specified intervals, including 3 weeks after starting the DFV890 dosing period and after a single dose of MAS825.
Step 4
Completion of study
At the end of the study period, a final assessment is conducted. This includes a comprehensive evaluation of the participant's health status and any changes in inflammatory markers.
Participants are provided with information about the study's findings and any relevant health advice based on their participation.

Who can join the trial?

5 criteria

Participants must be men or women aged between 18 and 80 years old at the start of the screening process.
Participants should have a body mass index (BMI) between 18 and 40 kg/m². BMI is a measure that uses your weight and height to determine if you are in a healthy weight range.
Participants must have had a documented spontaneous myocardial infarction (MI), which is a type of heart attack, at least 30 days before the start of the screening. This should be diagnosed according to standard criteria, with or without specific changes seen on an ECG test.
Participants should have a known presence of CHIP, which stands for clonal hematopoiesis of indeterminate potential. This is limited to specific genetic changes called driver mutations in genes named TET2 or DNMT3A, with a variant allele frequency (VAF) of 2% or more, as recorded in their medical history.
If participants are taking statin therapy, which is medication used to lower cholesterol, they must be on a stable dose for at least 4 weeks before the trial starts, with no planned changes in the dose during the trial. However, unplanned changes in the dose may happen during the trial.

Who cannot join the trial?

10 criteria

Participants with any other serious health condition that might interfere with the study.
Individuals who are currently participating in another clinical trial.
People who have had a recent heart attack or stroke.
Participants with uncontrolled high blood pressure.
Individuals with severe liver or kidney disease.
People who are pregnant or breastfeeding.
Participants with a history of allergic reactions to similar medications.
Individuals with a history of drug or alcohol abuse.
People who have been diagnosed with cancer in the past five years.
Participants with any condition that the study doctors believe would make it unsafe to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Rheinische Friedrich-Wilhelms-Universitaet Bonn
Bonn, Germany

Trial locations

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Investigated drugs

DFV890
is a medication being studied for its potential to lower levels of inflammatory markers in people with coronary heart disease and a condition known as Clonal Hematopoiesis of Indeterminate Potential (CHIP). The goal is to see if this medication can help reduce inflammation, which is often linked to heart disease.
MAS825
is another medication being tested in the same study. Like DFV890, it is being evaluated for its ability to decrease inflammation in individuals with coronary heart disease and CHIP. The study aims to determine if MAS825 can effectively lower the levels of substances in the blood that indicate inflammation.

What is already known about the treatment

DFV890
DFV890 is administered orally and is currently being studied in clinical trials for its potential to reduce inflammatory markers in individuals with coronary heart disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP). It is in the Phase 2a stage of clinical research, indicating that it is still under investigation and not yet approved for general medical use. The main therapeutic indication for DFV890 is atherosclerotic cardiovascular disease. At the molecular level, DFV890 works by targeting specific pathways involved in inflammation, aiming to decrease the levels of inflammatory markers in the bloodstream. It is classified pharmacologically as an anti-inflammatory agent.
MAS825
MAS825 is also administered orally and is being evaluated in clinical trials for its ability to lower inflammatory markers in patients with coronary heart disease and CHIP. Like DFV890, it is in the Phase 2a stage, meaning it is still being tested for safety and efficacy. The primary therapeutic indication for MAS825 is atherosclerotic cardiovascular disease. Its mechanism of action involves modulating inflammatory pathways to reduce inflammation in the body. MAS825 is classified as an anti-inflammatory medication.

Investigated diseases

Atherosclerotic cardiovascular disease – This disease involves the buildup of fatty deposits, known as plaques, inside the arteries. Over time, these plaques can harden and narrow the arteries, reducing blood flow to vital organs. The progression of the disease can lead to complications such as chest pain or heart attacks if the blood supply to the heart is significantly reduced. It can also cause strokes if the blood flow to the brain is affected. The disease often develops slowly over many years and may not show symptoms until the arteries are severely narrowed or blocked. Lifestyle factors such as diet, exercise, and smoking can influence its progression.