NCT06500702

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

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Conditions

• Focal Segmental Glomerulosclerosis
• Glomerulonephritis Minimal Lesion

Interventions

Type	Name	Description
DRUG	frexalimab	frexalimab treatment
DRUG	brivekimig	brivekimig treatment
DRUG	rilzabrutinib	rilzabrutinib treatment
DRUG	placebo	placebo treatment

Timeline

• Start date: 2024-12-19
• Primary completion: 2026-12-23
• Completion: 2028-02-16
• First posted: 2024-07-15
• Last updated: 2026-04-09

Locations

69 sites across 22 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Poland, Portugal, Slovakia, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study