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RecruitingPhase 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

Sanofi · NCT06500702

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
84
US sites recruiting
17
Study start
December 19, 2024
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: frexalimab; brivekimig; rilzabrutinib; placebo

Conditions: Focal Segmental Glomerulosclerosis; Glomerulonephritis Minimal Lesion

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show 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.

Recruiting US locations

  • University of Alabama -The Kirklin Clinic- Site Number : 8400007

    Birmingham, AL 35233

  • University of California Irvine Medical Center- Site Number : 8400015

    Orange, CA 92868

  • University of California San Francisco - Parnassus Heights- Site Number : 8400012

    San Francisco, CA 94143

  • University Of South Florida - Parent- Site Number : 8400025

    Tampa, FL 33612

  • Emory Children's Center- Site Number : 8400020

    Atlanta, GA 30322

  • Northwestern Memorial Hospital- Site Number : 8400014

    Chicago, IL 60611

  • Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017

    Hinsdale, IL 60521

  • University of Michigan Health System - Ann Arbor- Site Number : 8400010

    Ann Arbor, MI 48109

  • InterMed Consultants - Edina Clinic- Site Number : 8400019

    Edina, MN 55435

  • Renal Medicine Associates- Site Number : 8400028

    Albuquerque, NM 87109

  • Columbia University Irving Medical Center- Site Number : 8400001

    New York, NY 10032

  • The Children's Hospital at Montefiore- Site Number : 8400027

    The Bronx, NY 10467

  • UNC Kidney Center- Site Number : 8400021

    Chapel Hill, NC 27599

  • Cleveland Clinic - Cleveland- Site Number : 8400029

    Cleveland, OH 44195

  • Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024

    Dallas, TX 75204

  • El Paso Kidney Specialists- Site Number : 8400005

    El Paso, TX 79902

  • Prolato Clinical Research Center- Site Number : 8400016

    Houston, TX 77054

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
A Study to Evaluate the Efficacy and Safety of Frexalimab,… (NCT06500702) | Bored Studies