NCT06097663

A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

A Randomized, Placebo-controlled, Parallel-group, Investigator- and Participant-blinded Phase 2a Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in an Adult Population With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 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, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (variant allele frequency \[VAF\] ≥2%).

Detailed description

This was a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study. The study consisted of a screening period up to 30 days; a treatment period of approximately 12 weeks with an end of treatment (EOT) visit on Day 85, which is one day after the last dose of DFV890 or placebo; 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 21 weeks. Participants were randomized to one of five treatment sequences. Based on the treatment sequence assignments, participants started on either a combination of MAS825 and placebo, DFV890 and placebo, or placebo and placebo on Day 1, and then, within each DFV890 treatment sequence, participants received up-titrating doses of DFV890 or placebo at the corresponding study visits. None of the treatment sequences included a combination of both active DFV890 and active MAS825.

Conditions

• Coronary Heart Disease
• Clonal Hematopoiesis of Indeterminate Potential (CHIP)

Interventions

Type	Name	Description
DRUG	MAS825	Active MAS825 single dose
DRUG	MAS825 Placebo	MAS825 placebo single dose
DRUG	DFV890	Oral tablet of DFV890 active once daily
DRUG	DFV890 placebo	Oral tablet of DFV890 placebo once daily

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-10-27
• Completion: 2024-11-04
• First posted: 2023-10-24
• Last updated: 2026-04-09
• Results posted: 2026-03-27

Locations

6 sites across 3 countries: United States, Canada, Germany

Regulatory

• FDA-regulated drug study