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 (RESULT)
Actively Recruiting
About This Study
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled umbrella study evaluates the efficacy and safety of three investigational agents—frexalimab, brivekimig, and rilzabrutinib—in patients aged 16 to 75 with primary FSGS or MCD. The primary objective is to assess changes in proteinuria and nephrotic syndrome remission rates over a 24-week treatment period. Participants are randomized across six treatment arms to compare these novel therapies against placebo. Key clinical outcomes focus on reductions in UPCR and the achievement of complete or partial clinical remission. The total study duration lasts up to 76 weeks, including a long-term follow-up phase to monitor safety and durability of response.
Who Can Participate?
✓ Inclusion Criteria
- •Biopsy-proven primary FSGS or primary MCD.
- •UPCR ≥3 g/g at screening.
- •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 to randomization.
- •On stable dose of RAAS for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
- •On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment or changing the dose will not be allowed during the double-blind or OLE treatment periods.
- •Body weight within 45 to 120 kg (inclusive) at screening.
✗ Exclusion Criteria
- •Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
- •Collapsing variant of FSGS.
- •ESKD requiring dialysis or transplantation. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.