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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506741-34-00

Acronym

CADPT15A12201

Enrollment

Registered

2024-02-08

Start date

2024-02-16

Completion date

2024-11-04

Last updated

2024-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerotic cardiovascular disease

Brief summary

Serum levels of IL-6 and IL-18 at 3 weeks after the start of a DFV890 dosing period, Serum level of IL-6 at 3 weeks after a single s.c. dose of MAS825

Detailed description

Adverse events, and parameters from safety assessments, including vital signs, electrocardiograms (ECGs), and laboratory assessments (urine and blood), Plasma trough concentrations (Ctrough) of DFV890 at steady-state, Serum concentrations of MAS825 after a single s.c. dose of MAS825

Interventions

DRUGDFV890

DRUGPlacebo to MAS825 100 mg/1 mL Solution for Injection

DRUGPlacebo to DFV890 10 mg and 25 mg film-coated tablet

DRUGMAS825

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Serum levels of IL-6 and IL-18 at 3 weeks after the start of a DFV890 dosing period, Serum level of IL-6 at 3 weeks after a single s.c. dose of MAS825	—

Secondary

Measure	Time frame
Adverse events, and parameters from safety assessments, including vital signs, electrocardiograms (ECGs), and laboratory assessments (urine and blood), Plasma trough concentrations (Ctrough) of DFV890 at steady-state, Serum concentrations of MAS825 after a single s.c. dose of MAS825	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026