Phase 2a Study to Test Frexalimab, Brivekimig, or Rilzabrutinib for Adults Aged 16 to 75 with Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

What this Trial Is About

Researchers are evaluating the effects of three drugsfrexalimab, brivekimig, and rilzabrutinibcompared with a placebo in people aged 16 to 75 years who have primary focal segmental glomerulosclerosis FSGS or minimal change disease MCD. This Phase 2a, double-blind study aims to measure changes in proteinuria and how these changes impact remission rates of nephrotic syndrome in this population. Participants will be randomly assigned to one of six groups receiving either active doses of frexalimab, brivekimig, rilzabrutinib, or a matching placebo. The treatment period lasts 24 weeks within an overall study duration of up to 52 weeks. During this time, participants will attend up to 16 visits for treatment administration and monitoring. Throughout the study, participants will undergo regular assessments including measurement of urine protein to creatinine ratio UPCR at baseline and Week 12, evaluation of remission endpoints, and monitoring for adverse events up to Week 48. Blood samples will be taken to measure drug concentrations and check for anti-drug antibodies. The study involves careful safety monitoring and follow-up visits to assess treatment effects and participant well-being.

A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease