NCT06031844

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

A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Elevated hsCRP

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This was 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 consisted 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 was 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. Participants meeting all eligibility criteria were 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 was uptitrated (according to the specific treatment sequence that the participant was assigned to) approximately every three weeks at the scheduled visits on Days 22, 43 and 64.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	DFV890	Oral film-coated tablets of DFV890 once daily
DRUG	DFV890 Placebo	Oral film-coated tablets of DFV890 placebo once daily

Timeline

• Start date: 2023-10-16
• Primary completion: 2024-12-17
• Completion: 2024-12-23
• First posted: 2023-09-11
• Last updated: 2026-04-09
• Results posted: 2026-03-27

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study