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)
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%).
Timeline
- Start
- 2024-02-15
- Primary completion
- 2024-10-27
- Completion
- 2024-11-04
Outcome
Met primary endpoint
registry analysis (superiority test); DFV890 25 mg vs Placebo; p = 0.008; Ratio of the Geometric Mean 0.6737 (80% CI 0.5528 to 0.8210); Emax model NCT06097663 ↗
registry analysis (superiority test); DFV890 100 mg vs Placebo; p = 0.007; Ratio of the Geometric Mean 0.9304 (80% CI 0.8982 to 0.9638); Emax model NCT06097663 ↗
registry analysis (superiority test); MAS825 vs Placebo; p = 0.0008; Ratio of the Geometric Mean 0.4770 (80% CI 0.3561 to 0.6388); Regression, Linear NCT06097663 ↗
Publications
- Sumida K, Obeng EA, Kovesdy CP. Clonal Hematopoiesis in Kidney Disease. Clin J Am Soc Nephrol. 2026 Apr 1;21(4):719-721. doi: 10.2215/CJN.0000000895. Epub 2025 Sep 11. No abstract available.
- Avolio E, Bassani B, Campanile M, Mohammed KA, Muti P, Bruno A, Spinetti G, Madeddu P. Shared molecular, cellular, and environmental hallmarks in cardiovascular disease and cancer: Any place for drug repurposing? Pharmacol Rev. 2025 Mar;77(2):100033. doi: 10.1016/j.pharmr.2024.100033. Epub 2024 Dec 24.