drugset / Trial / 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)

NCT06097663

Phase 2 Completed 31 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject DFV890 Unknown 100 mg Oral
Subject MAS825 Monoclonal antibody Subcutaneous