Clinical Research Directory
Browse clinical research sites, groups, and studies.
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)
Sponsor: Novartis Pharmaceuticals
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%).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-02-15
Completion Date
2024-11-04
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
MAS825
Active MAS825 single dose
MAS825 Placebo
MAS825 placebo single dose
DFV890
Oral tablet of DFV890 active once daily
DFV890 placebo
Oral tablet of DFV890 placebo once daily
Locations (6)
Washington University
St Louis, Missouri, United States
Vanderbilt University Medical Cent
Nashville, Tennessee, United States
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
München, Germany