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COMPLETED
NCT06097663
PHASE2

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

View on ClinicalTrials.gov

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

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

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