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Taking people in United StatesPhase 2

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

Key facts

Who runs it
Sanofi
Where
Albuquerque, Ann Arbor, Atlanta, Birmingham, Chapel Hill, Chicago, Cleveland, Dallas, Edina, El Paso, Hinsdale, Houston, Las Vegas, New York, Orange, San Francisco, Tampa, and The Bronx, United StatesSee the 18 sitesAlso in 21 other countries, 64 sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
84 people, planned
Started
19 Dec 2024
Expected to end
16 Feb 2028
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • frexalimab
  • brivekimig
  • rilzabrutinib
  • placebo
Record updated
12 November 2026

Who can take part

Age
16 years to 75 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible
  • Collapsing variant of FSGS

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 16 and 75 years old?

Where in United States

Also in 21 other countries, 64 sites

  • Albuquerque, New MexicoHospital not named in the registryTaking people
  • University of Michigan Health System - Ann Arbor- Site Number : 8400010Ann Arbor, United StatesTaking people
  • Emory Children's Center- Site Number : 8400020Atlanta, United StatesTaking people
  • University of Alabama -The Kirklin Clinic- Site Number : 8400007Birmingham, United StatesTaking people
  • UNC Kidney Center- Site Number : 8400021Chapel Hill, United StatesTaking people
  • Northwestern Memorial Hospital- Site Number : 8400014Chicago, United StatesTaking people
  • Cleveland Clinic - Cleveland- Site Number : 8400029Cleveland, United StatesTaking people
  • Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024Dallas, United StatesTaking people
  • InterMed Consultants - Edina Clinic- Site Number : 8400019Edina, United StatesTaking people
  • El Paso Kidney Specialists- Site Number : 8400005El Paso, United StatesTaking people
  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017Hinsdale, United StatesTaking people
  • Prolato Clinical Research Center- Site Number : 8400016Houston, United StatesTaking people
  • DaVita Clinical Research - Las Vegas - North Rainbow Boulevard- Site Number : 8400018Las Vegas, United StatesNo longer taking part
  • Columbia University Irving Medical Center- Site Number : 8400001New York, United StatesTaking people
  • University of California Irvine Medical Center- Site Number : 8400015Orange, United StatesTaking people
  • University of California San Francisco - Parnassus Heights- Site Number : 8400012San Francisco, United StatesTaking people
  • University Of South Florida - Parent- Site Number : 8400025Tampa, United StatesTaking people
  • The Children's Hospital at Montefiore- Site Number : 8400027The Bronx, United StatesTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 4 groups in the trial

  • FrexalimabTreatment being tested

    Frexalimab active dose

  • BrivekimigTreatment being tested

    Brivekimig active dose

  • RilzabrutinibTreatment being tested

    Rilzabrutinib active dose

  • PlaceboPlacebo, for comparison

    Matching placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Fit questions
Built from NCT06500702, who can take part
Record updated
12 November 2026