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

NCT06031844 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CDFV890F12201
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 7

Brief Summary

This Phase 2a clinical trial evaluated 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.

Conditions

Coronary Heart Disease

Keywords

DFV890; Phase 2a; coronary heart disease; elevated hsCRP

Outcome Measures

Primary Outcomes (2)

• Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model

  Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.

  Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)

• Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model

  Serum levels of IL-18 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-18 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor.The Emax model selected for IL-18 analysis was a model with 2 covariates (IL-18 baseline and bodyweight) and 1 random effect.

  Baseline (before first dose of study drug), 3 weeks after the start of a dosing period for DFV890 (between Day 22 and Day 85, depending on treatment sequence assignment)

Secondary Outcomes (1)

• Trough Plasma Concentration (Ctrough)

  After the last dose of each 3-week dosing period: Day 22 pre-dose, Day 43 pre-dose, Day 64 pre-dose, or Day 85, depending on treatment sequence assignment

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 10 mg QD. The dose of DFV890 was uptitrated to 25 mg on Day 43 and to 100 mg on Day 64.

Drug: DFV890; Drug: DFV890 Placebo

Treatment sequence 2

EXPERIMENTAL

On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.

Drug: DFV890; Drug: DFV890 Placebo

Treatment sequence 3

EXPERIMENTAL

On Day 1, participants received 1 tablet of DFV890 10 mg QD. Participants continued receiving DFV890 10 mg QD until Day 22 when they started receiving DFV890 25 mg QD. The dose of DFV890 was uptitrated to 50 mg on Day 43 and to 100 mg on Day 64.

Drug: DFV890

Treatment sequence 4

PLACEBO COMPARATOR

On Day 1, participants received 1 tablet of DFV890 matching placebo QD. Participants continued receiving DFV890 oral placebo QD until Day 84.

Drug: DFV890 Placebo

Interventions

DFV890 DRUG

Oral film-coated tablets of DFV890 once daily

Treatment Sequence 1; Treatment sequence 2; Treatment sequence 3

DFV890 Placebo DRUG

Oral film-coated tablets of DFV890 placebo once daily

Treatment Sequence 1; Treatment sequence 2; Treatment sequence 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants aged between 18 - 85 years (inclusive) at the start of screening 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 the universal MI criteria with or without evidence of ST segment elevation) at least 30 days 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 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.
• For participants on statin therapy (HMG-CoA reductase inhibitor), as clinically indicated, participants must be on a stable regimen (at least 4 weeks before randomization), with no planned statin dose changes over the course of the trial treatment period. Unplanned statin dose changes during the trial treatment period may occur.

You may not qualify if:

• 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.
• Patients with suspected or proven immunocompromised state at screening
• History of ongoing, chronic, or major recurrent infectious disease, at the discretion 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 months prior to the start of screening.
• Symptomatic Class IV heart failure (New York Heart Association) at the start of screening.
• Planned coronary revascularization (PCI or CABG) or any other major surgical procedure during the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Valley Clinical Trials

Northridge, California, 91325, United States

Location

Excel Medical Clinical Trials LLC

Boca Raton, Florida, 33434, United States

Location

UF Health Science Center

Jacksonville, Florida, 32209, United States

Location

Triad Clinical Trials LLC

Greensboro, North Carolina, 27410, United States

Location

Monument Health Clinical Research

Rapid City, South Dakota, 57701, United States

Location

Universal Research Group LLC

Tacoma, Washington, 98405, United States

Location

Novartis Investigative Site

Montreal, Quebec, H1T 1C8, Canada

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 11, 2023
• Study Start: October 16, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 23, 2024
• Last Updated: April 9, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (6)