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Study of Frexalimab, Brivekimig, or Rilzabrutinib for FSGS or MCD

This study is looking at the safety and effectiveness of three different medications: frexalimab, brivekimig, or rilzabrutinib, compared to a placebo (an inactive substance). It's for people aged 16 to 75 who have primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), which are kidney conditions. The main goal is to see how much these medications can reduce the amount of protein in your urine, measured by your urine protein to creatinine ratio (UPCR), over 12 weeks. To join, you need to have a biopsy showing FSGS or MCD, and specific levels of protein in your urine and kidney function (eGFR).

Study design
This is a Phase 2a, double-blind study with 6 groups, meaning neither you nor your doctor will know if you are receiving one of the study medications or the placebo. About 84 participants are planned for this study.
What's involved
Your participation in the study will last up to 52 weeks, with treatment given for 24 weeks. You would have up to 16 visits during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of success (reduction in urine protein) is assessed from the start of the study up to Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06500702

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
PHASE2Ages 16–75InterventionalTreatment
Sanofi
~84 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:frexalimabbrivekimigrilzabrutinibplacebo

At a glance

Recruiting sites
71 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent reduction in urine protein to creatinine ratio (UPCR)
Measured over From baseline to Week 12

Conditions

Focal Segmental Glomerulosclerosis
Glomerulonephritis Minimal Lesion

Explore related trials

Focal Segmental GlomerulosclerosisMinimal Change GlomerulonephritisAPOL1 Gene

Where it's being run

71 sites across 46 states
Texas3
Quebec3
China3
Germany3
Greece3
Slovakia3
Spain3
California2

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
Collapsing variant of FSGS.
ESKD requiring dialysis or transplantation.

What this trial measures

  • Percent reduction in urine protein to creatinine ratio (UPCR)From baseline to Week 12