A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

Last updated: January 4, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Myocardial Ischemia

Chest Pain

Hypercholesterolemia

Treatment

Placebo

DFV890

Clinical Study ID

NCT06031844
CDFV890F12201
  • Ages 18-85
  • All Genders

Study Summary

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 24 people with known heart disease and an elevated marker of inflammation, hsCRP.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants aged between 18 - 85 years (inclusive) at the start ofscreening will be included.

  • Subjects must have a body mass index (BMI) within the range of 18 - 45 kg/m2. BMI =Body weight (kg) / [Height (m)]2

  • Documented spontaneous myocardial infarction (MI) (diagnosed according to theuniversal MI criteria with or without evidence of ST segment elevation) at least 30days before the start of screening.

  • 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 valuemust be a minimum of 30 days after the qualifying MI or after any percutaneouscoronary intervention (PCI) performed separately from the qualifying MI.

  • For participants on statin therapy (HMG-CoA reductase inhibitor), as clinicallyindicated, participants must be on a stable regimen (at least 4 weeks beforerandomization), with no planned statin dose changes over the course of the trialtreatment period. Unplanned statin dose changes during the trial treatment periodmay occur.

Exclusion

Exclusion Criteria:

  • Patients receiving concomitant medications that are known to be strong or moderateinducers of cytochrome CYP2C9 enzyme and/or strong inducers of CYP3A, stronginhibitors of CYP2C9 and/or strong or moderate inhibitors of CYP3A and the treatmentcannot 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.

  • Patients with suspected or proven immunocompromised state at screening

  • History of ongoing, chronic, or major recurrent infectious disease, at thediscretion of the investigator, at the start of 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 6 monthsprior to the start of screening.

  • Symptomatic Class IV heart failure (New York Heart Association) at the start ofscreening.

  • Planned coronary revascularization (PCI or CABG) or any other major surgicalprocedure during the study.

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 16, 2023
Estimated Completion Date:
December 23, 2024

Study Description

This is a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study to evaluate the efficacy, safety, and tolerability of intra-individual dose escalation of DFV890 for inflammatory marker reduction in participants with coronary heart disease and elevated hsCRP. The study consists of a screening period of up to 60 days, a treatment period of approximately 12 weeks, an end of treatment (EOT) visit on Day 85, which is one day after the last dose on Day 84, 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 24 weeks and approximately 24 participants will be enrolled into the trial.

Participants meeting all eligibility criteria will be randomized in a 5:5:1:1 ratio to one of four treatment sequences (three DFV890 treatment sequences or a placebo-only sequence). The dose of DFV890 will be uptitrated (according to the specific treatment sequence that the participant is assigned to) approximately every three weeks at the scheduled visits on Days 22, 43 and 64.

Connect with a study center

  • Novartis Investigative Site

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Site Not Available

  • Valley Clinical Trials CPRT128A2302

    Northridge, California 91325
    United States

    Active - Recruiting

  • Excel Medical Clinical Trials LLC

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Novartis Investigative Site

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Jacksonville, Florida 32209-6511
    United States

    Active - Recruiting

  • University of Florida -Jacksonville UF Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • University of Florida Health Science Center

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Florida Health Science Center UF Health Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Greensboro, North Carolina 27410
    United States

    Active - Recruiting

  • Triad Clinical Trials LLC

    Greensboro, North Carolina 27410
    United States

    Site Not Available

  • Monument Health Clinical Research

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Monument Health Clinical Research A Depart Of Monument Health

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Tacoma, Washington 98405
    United States

    Active - Recruiting

  • Universal Research Group LLC

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Universal Research Group LLC Suite 202

    Tacoma, Washington 98405
    United States

    Active - Recruiting

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