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

Study of Treatments for Primary FSGS or MCD

Recruiting
16 years - 75 years
All
Phase 2
84 participants needed
2 Locations

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
  • Age: 16 years - 75 years
  • Gender: All

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.

This study investigates the effectiveness and safety of three investigational medications compared to a placebo in treating primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD). These kidney disorders can lead to nephrotic syndrome, characterized by high levels of protein in the urine (proteinuria). The purpose of this study is to measure changes in proteinuria and assess remission rates of nephrotic syndrome in participants aged 16 to 75 years.

Participants in this study will be randomly assigned to one of six study arms, receiving either one of the investigational medications or a placebo. The study will include various procedures such as blood tests, urine tests, and physical examinations to monitor the health and progress of participants. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.

  • Who can participate: Individuals aged 16 to 75 years with biopsy-proven primary FSGS or primary MCD may participate. Key eligibility factors include having a UPCR of at least 3 g/g at screening and an eGFR of at least 45 mL/min/1.73 m^2. Participants should have a history of proteinuria reduction in response to corticosteroid or other immunosuppressive therapy.
  • Study details: Participants will be assigned to one of six study arms, receiving either an investigational medication or a placebo. They will undergo regular assessments, including blood and urine tests, to monitor their condition. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines and visits: The study will last 76 weeks. The study requires 18 visits.
Updated on 30 Oct 2025. Study ID: NCT06500702

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