Phase 2 Study Evaluates Frexalimab, Brivekimig, Rilzabrutinib in FSGS and MCD

This Phase 2a, double-blind, parallel, 6-arm study aims to evaluate the efficacy and safety of frexalimab, brivekimig, and rilzabrutinib in patients aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The study will enroll 84 participants and will last up to 76 weeks, with a treatment duration of 24 weeks. Participants will attend up to 18 visits. The primary endpoint is the percent reduction in urine protein to creatinine ratio (UPCR), which serves as a measure of proteinuria reduction. Secondary endpoints and detailed safety profiles will be assessed, although specific statistics such as hazard ratios, odds ratios, or confidence intervals are not yet available. The trial is sponsored by Sanofi and is currently recruiting, with an estimated primary completion date of December 23, 2026. The study's outcomes could potentially inform treatment strategies for FSGS and MCD, focusing on reducing proteinuria as a key therapeutic target.

This study focuses on two kidney diseases: primary focal segmental glomerulosclerosis (FSGS) and primary minimal change disease (MCD). These conditions can cause serious problems, including swelling and high protein levels in urine. Researchers are testing three new drugs—frexalimab, brivekimig, and rilzabrutinib—compared to a placebo, which is a dummy treatment with no active ingredients. Over about 76 weeks, they will see how much these drugs can lower protein levels in urine, which is an important sign of kidney health. If successful, these treatments could help many patients manage their symptoms better and improve their quality of life. However, it’s important to remember that this is still a research study, and the drugs are not yet widely available. Patients interested in participating should talk to their doctors for more information.