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 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 MCD aged 16 to 75 years. Study details for each participant include: The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.
Eligibility
- Age range
- 16–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Biopsy report indicative of primary FSGS or 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 mL/min/1.73 m2. * eGFR ≥45 mL/min/1.73 m\^2 at screening. * Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for…
Interventions
- Drugfrexalimab
frexalimab treatment
- Drugbrivekimig
brivekimig treatment
- Drugrilzabrutinib
rilzabrutinib treatment
- Drugplacebo
placebo treatment
Locations (75)
- University of Alabama -The Kirklin Clinic- Site Number : 8400007Birmingham, Alabama
- University of California Irvine Medical Center- Site Number : 8400015Orange, California
- University of California San Francisco - Parnassus Heights- Site Number : 8400012San Francisco, California
- University Of South Florida - Parent- Site Number : 8400025Tampa, Florida
- Emory Children's Center- Site Number : 8400020Atlanta, Georgia
- Northwestern Memorial Hospital- Site Number : 8400014Chicago, Illinois