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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

RecruitingPhase 2

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)

Who can join

Ages 16 to 75 · All sexes

Full eligibility 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.

About the study

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.

What is being tested

Sponsor: Sanofi · Participants: 84 · Started: Dec 19, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06500702

Locations in the U.S.

AlabamaUniversity of Alabama -The Kirklin Clinic- Site Number : 8400007, Birmingham
CaliforniaUniversity of California Irvine Medical Center- Site Number : 8400015, Orange
University of California San Francisco - Parnassus Heights- Site Number : 8400012, San Francisco
FloridaUniversity Of South Florida - Parent- Site Number : 8400025, Tampa
GeorgiaEmory Children's Center- Site Number : 8400020, Atlanta
IllinoisNorthwestern Memorial Hospital- Site Number : 8400014, Chicago
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017, Hinsdale
MichiganUniversity of Michigan Health System - Ann Arbor- Site Number : 8400010, Ann Arbor
MinnesotaInterMed Consultants - Edina Clinic- Site Number : 8400019, Edina
NevadaDaVita Clinical Research - Las Vegas - North Rainbow Boulevard- Site Number : 8400018, Las Vegas
New MexicoRenal Medicine Associates- Site Number : 8400028, Albuquerque
New YorkColumbia University Irving Medical Center- Site Number : 8400001, New York
The Children's Hospital at Montefiore- Site Number : 8400027, The Bronx
North CarolinaUNC Kidney Center- Site Number : 8400021, Chapel Hill
OhioCleveland Clinic - Cleveland- Site Number : 8400029, Cleveland
TexasRenal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024, Dallas
El Paso Kidney Specialists- Site Number : 8400005, El Paso
Prolato Clinical Research Center- Site Number : 8400016, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.