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Looking for participantsPhase2

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

Sponsor: Sanofi

NCT ID: NCT06500702

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
frexalimab (drug), brivekimig (drug), rilzabrutinib (drug), placebo (drug)
How long the study runs
Study runs about 38 months (dates as stated)
About the drug or intervention
frexalimab — drug: frexalimab treatment · brivekimig — drug: brivekimig treatment · rilzabrutinib — drug: rilzabrutinib treatment · placebo — drug: placebo treatment
Patient visit burden
"There will be up to 16 visits." (as stated by sponsor)
Type of study
Testing a treatment
Ages
16 Years to 75 Years
Who
All
Number of participants
84
Started
2024-12-19
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for focal segmental glomerulosclerosis
  • • Phase2 - 84 participants
  • • 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)

Who can take part?

  • • Ages 16 Years to 75 Years
  • • Diagnosed with focal segmental glomerulosclerosis

Where?

  • • Leicester - Investigational Site Number : 8260001
  • • Salford - Investigational Site Number : 8260004
  • • Oxford - Investigational Site Number : 8260005

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Focal Segmental GlomerulosclerosisGlomerulonephritis Minimal Lesion

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓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.
  • ✓≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
  • ✓Body weight within 45 to 120 kg (inclusive) at screening.

Who cannot take part

  • ✗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...
See the full criteria
Inclusion Criteria: * 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 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.

Where Is This Study? (3 UK sites)

Investigational Site Number : 8260001

Leicester LE5 4PW, United Kingdom

Recruiting

Investigational Site Number : 8260004

Salford M6 8HD, United Kingdom

Recruiting

Investigational Site Number : 8260005

Oxford OX3 7LE, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 contact-us@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09