← Klinické štúdie • Glomerulopatie
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)
Stručný súhrn
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.
Základné údaje
| Ochorenia | Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion |
|---|---|
| Intervencie |
DRUG: frexalimab DRUG: brivekimig DRUG: rilzabrutinib DRUG: placebo |
| Sponzor | Sanofi |
| Plánovaný počet | 84 |
| Začiatok | 2024-12-19 |
| Predp. ukončenie (primárne) | 2026-12-23 |
| Krajiny | 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 |
| Posledná aktualizácia | 2026-06-08 |