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Anti-inflammatory Agent

DFV890 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
Male and female participants aged between 18 - 80 years (inclusive) at the start of screening will be included.
Participants must have hsCRP levels ≥ 2 mg/L at two timepoints during screening. Screening values must be separated by a minimum of 8 days. The initial hsCRP value must be a minimum of 30 days after the qualifying MI or after any percutaneous coronary intervention (PCI) performed separately from the qualifying MI.
Must not have
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.
Multi-vessel Coronary Artery Bypass Graft (CABG) surgery within the past 3 years prior to the start of screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 22 to end of study visit (up to 92 days)
Awards & highlights

Summary

This trial will test a daily pill to reduce inflammation markers linked to heart disease in 24 people with existing heart issues.

Who is the study for?
Adults aged 18-80 with coronary heart disease who are on a stable statin regimen and have high levels of inflammation markers (hsCRP ≥ 2 mg/L). They must not have plans for heart surgery during the study, no recent major infections or immune-targeting biologic drug use, and should not be taking certain other medications.
What is being tested?
The trial is testing DFV890, an oral medication given daily for 12 weeks to see if it can lower inflammation related to cardiovascular risk in people with heart disease. It's compared against a placebo to check its effectiveness and safety.
What are the potential side effects?
While specific side effects of DFV890 aren't listed, common risks may include gastrointestinal issues, allergic reactions, potential liver impact due to drug interactions, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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My hsCRP levels were 2 mg/L or higher at two different times after my heart attack.
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My BMI is between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on strong medication that affects liver enzymes and can't switch before the study.
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I had heart bypass surgery for multiple blocked arteries within the last 3 years.
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I have severe heart failure symptoms.
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I am scheduled for a major heart or other surgery during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 22 to end of study visit (up to 92 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 22 to end of study visit (up to 92 days) 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 levels of IL-6 and IL-18
Secondary study objectives
Plasma trough concentrations (Ctrough) of DFV890 at steady state

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment sequence 3Experimental Treatment1 Intervention
Participants will be administered different doses of DFV890
Group II: Treatment sequence 2Experimental Treatment2 Interventions
Participants will be administered Placebo and different doses of DFV890
Group III: Treatment Sequence 1Experimental Treatment2 Interventions
Participants will be administered Placebo and different doses of DFV890
Group IV: Treatment sequence 4Placebo Group1 Intervention
Participants will be administered Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFV890
2021
Completed Phase 2
~150
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,980 Total Patients Enrolled
~7 spots leftby Mar 2025
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