Summary

Eligibility
for people ages 16-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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, SAR442970, 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.

Official Title

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Keywords

Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion, Glomerulonephritis, Lipoid Nephrosis, frexalimab, SAR442970, rilzabrutinib

Eligibility

You can join if…

Open to people ages 16-75

  • Biopsy-proven primary FSGS or primary MCD.
  • UPCR ≥3 g/g at screening.
  • eGFR ≥45 mL/min/1.73 m2 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.

You CAN'T join if...

  • 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.

Locations

  • Investigational Site Number : 8400012 accepting new patients
    San Francisco California 94143 United States
  • Investigational Site Number : 8400005 accepting new patients
    El Paso Texas 79902 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sanofi
ID
NCT06500702
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated