A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Launched by SANOFI · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of three different treatments—frexalimab, SAR442970, and rilzabrutinib—in patients aged 16 to 75 years with specific kidney conditions called primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD). The main goal is to see how these treatments can reduce protein in the urine, which is a sign of kidney problems, and help patients achieve remission from nephrotic syndrome, a condition that can cause swelling and other health issues.

To be eligible for the trial, participants must have a confirmed diagnosis of FSGS or MCD, show a certain level of protein in their urine, and have stable kidney function. They should also have previously responded well to steroid treatments. The study will last up to 76 weeks, with participants receiving treatment for 24 weeks and attending up to 18 study visits. It's important to note that those with other types of kidney disease or those on certain medications may not be eligible. This trial is a chance for patients to contribute to research that could improve future treatments for these kidney conditions.

Gender

ALL

Eligibility criteria

• 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 reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.
• • ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
• • On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment 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 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.