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)
Sanofi
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.
Eligibility
- Age range
- 16–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy report indicative of primary FSGS or primary MCD, with supportive clinical presentation per Investigator's judgement. * UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60. * eGFR ≥45 mL/min/1.73 m\^2 at screening. * Documented history of UPCR (or 24-hour urine protein) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used). * ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior…
Interventions
- Drugfrexalimab
frexalimab treatment
- Drugbrivekimig
brivekimig treatment
- Drugrilzabrutinib
rilzabrutinib treatment
- Drugplacebo
placebo treatment
Locations (69)
- Investigational Site Number : 8400007Birmingham, Alabama
- Investigational Site Number : 8400015Orange, California
- Investigational Site Number : 8400012San Francisco, California
- Investigational Site Number : 8400025Tampa, Florida
- Investigational Site Number : 8400014Chicago, Illinois
- Investigational Site Number : 8400017Hinsdale, Illinois