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Anti-inflammatory Agent

Treatment Sequence 1 for Coronary Heart Disease

Phase 2

Recruiting

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 22 to day 92

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 22 to day 92

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum level of IL-6

Serum levels of IL-6 and IL-18

Secondary outcome measures

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,198,281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this investigation currently open?

"As per clinicaltrials.gov, recruitment for this study is ongoing. The trial was initially listed on 16th February 2024 and received its latest update on 19th February 2024."

Answered by AI

What are the risks associated with Treatment Sequence 2 in terms of patient safety?

"Team at Power has evaluated the safety of Treatment Sequence 2 to be a 2 on the scale, considering this is a Phase 2 trial with some evidence supporting its safety but lacking efficacy data."

Answered by AI

What is the current number of individuals being selected to participate in this clinical investigation?

"Indeed, details listed on clinicaltrials.gov indicate that recruitment is ongoing for this trial. The study was initially posted on February 16th, 2024 and last revised on February 19th, 2024. A total of 28 participants are sought from two distinct locations."

Answered by AI