Phase 2a trial of DFV890 and MAS825 for inflammation in CHD/CHIP patients completes with 31 participants

Status: COMPLETED | Phase: PHASE2 Condition(s): Coronary Heart Disease, Clonal Hematopoiesis of Indeterminate Potential (CHIP) Intervention(s): MAS825 (DRUG), MAS825 Placebo (DRUG), DFV890 (DRUG), DFV890 placebo (DRUG) 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%). Detailed: This was a multi-center, randomized, placebo-controlled, participant- and investigator-blinded study. The study consisted of a screening period up to 30 days; a treatment period of approximately 12 weeks with an end of treatment (EOT) visit on Day 85, which is one day after the last dose of DFV890 or placebo; a follow-up period of approximately 1 week; and a standard safety follow-up call approximately 30 days following the last dose. The overall study duration is approximately 21 weeks. Participants were randomized to one of five treatment sequences. Based on the treatment sequence assignments, participants started on either a combination of MAS825 and placebo, DFV890 and placebo, or placebo and placebo on Day 1, and then, within each DFV890 treatment sequence, participants received up- Primary Outcome(s): Ratio to Baseline Serum Levels of IL-6 for DFV890 Based on an Emax Model; Ratio to Baseline Serum Levels of IL-18 for DFV890 Based on an Emax Model; Ratio to Baseline Serum Levels of IL-6 for MAS825 Based on a Traditional Linear Regression Model Enrollment: 31 (ACTUAL) Lead Sponsor: Novartis Pharmaceuticals Start: 2024-02-15 | Primary Completion: 2024-10-27 Results posted: 2026-03-27