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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion

In brief

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.

Key facts

Study ID: NCT06500702
Run by: Sanofi
People needed: 84
Starts: 2024-12-19
Expected to finish: 2028-02-16
Last updated by the study team: 2026-07-20

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 24-hr urine albumin if 24-hour urine albumin is used).
≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeks prior to screening; 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.

You may not qualify 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.

Where it is running

Investigational Site Number : 8400015 — Orange, California, United States (enrolling)
Investigational Site Number : 8400012 — San Francisco, California, United States (enrolling)
Investigational Site Number : 8400025 — Tampa, Florida, United States (enrolling)
Emory Children's Center- Site Number : 8400020 — Atlanta, Georgia, United States (enrolling)
Investigational Site Number : 8400014 — Chicago, Illinois, United States (enrolling)
Investigational Site Number : 8400017 — Hinsdale, Illinois, United States (enrolling)
Investigational Site Number : 8400010 — Ann Arbor, Michigan, United States (enrolling)
Investigational Site Number : 8400019 — Edina, Minnesota, United States (enrolling)
Investigational Site Number : 8400018 — Las Vegas, Nevada, United States (enrolling)
Investigational Site Number: 8400028 — Albuquerque, New Mexico, United States (enrolling)
Investigational Site Number : 8400001 — New York, New York, United States (enrolling)
Investigational Site Number : 8400021 — Chapel Hill, North Carolina, United States (enrolling)
Investigational Site Number : 8400024 — Dallas, Texas, United States (enrolling)
Investigational Site Number : 8400005 — El Paso, Texas, United States (enrolling)
Investigational Site Number: 8400016 — Houston, Texas, United States (enrolling)
Investigational Site Number : 0320001 — Buenos Aires, Argentina (enrolling)
Investigational Site Number : 0320002 — Córdoba, Argentina (enrolling)
Investigational Site Number : 0360003 — Garran, Australian Capital Territory, Australia (enrolling)
Investigational Site Number : 0360001 — Parkville, Victoria, Australia (enrolling)
Investigational Site Number: 0760004 — Botucatu, São Paulo, Brazil (enrolling)
Synvia Clinical- Site Number : 0760005 — São Paulo, São Paulo, Brazil (enrolling)
Investigational Site Number : 0760002 — São Paulo, Brazil (enrolling)
Investigational Site Number : 0760001 — São Paulo, Brazil (enrolling)
Investigational Site Number : 1240002 — London, Ontario, Canada (enrolling)
Investigational Site Number : 8400007 — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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