A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Last updated: April 21, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Kidney Disease

Glomerulonephritis

Nephrotic Syndrome

Treatment

placebo

frexalimab

rilzabrutinib

Clinical Study ID

NCT06500702
ACT18064
U1111-1301-2676
2024-511775-15
  • Ages 16-75
  • All Genders

Study Summary

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary 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, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.

Study details for each participant include:

The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Biopsy-proven primary FSGS or primary MCD.

  • UPCR ≥3 g/g at screening.

  • eGFR ≥45 mL/min/1.73 m^2 at screening.

  • Documented history of UPCR reduction by ≥40% in response to corticosteroid or otherimmunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.

  • ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior torandomization.

  • On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable);starting RAAS inhibitors treatment will not be allowed during the double-blind orOLE treatment period.

  • On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable);starting SGLT2 inhibitor treatment will not be allowed during the double-blind orOLE treatment periods.

  • Body weight within 45 to 120 kg (inclusive) at screening.

Exclusion

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.

Study Design

Total Participants: 84
Treatment Group(s): 4
Primary Treatment: placebo
Phase: 2
Study Start date:
December 19, 2024
Estimated Completion Date:
February 16, 2028

Connect with a study center

  • Investigational Site Number : 0320002

    Cordoba, Córdoba X5016KET
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0360001

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Investigational Site Number : 0760001

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Investigational Site Number : 1240001

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240006

    Quebec City, Quebec G1R 2J6
    Canada

    Active - Recruiting

  • Investigational Site Number : 1520002

    Santiago, 8320000
    Chile

    Active - Recruiting

  • Investigational Site Number : 1560001

    Beijing, 100034
    China

    Active - Recruiting

  • Investigational Site Number : 1560003

    Chengdu, 610072
    China

    Active - Recruiting

  • Investigational Site Number : 1560004

    Shanghai, 200080
    China

    Active - Recruiting

  • Investigational Site Number : 2500002

    Créteil, 94010
    France

    Active - Recruiting

  • Investigational Site Number : 2500001

    Paris, 75015
    France

    Active - Recruiting

  • Investigational Site Number : 2760002

    Berlin, 10117
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760003

    Hannover, 30625
    Germany

    Active - Recruiting

  • Investigational Site Number : 3000002

    Athens, 115 27
    Greece

    Active - Recruiting

  • Investigational Site Number : 3000001

    Heraklion, 711 10
    Greece

    Active - Recruiting

  • Investigational Site Number : 3800003

    Naples, Napoli 80131
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Brescia, 25123
    Italy

    Active - Recruiting

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 6160002

    Opole, 45-401
    Poland

    Active - Recruiting

  • Investigational Site Number : 6200001

    Matosinhos, 4464-513
    Portugal

    Active - Recruiting

  • Investigational Site Number : 6200002

    Porto, 4434-502
    Portugal

    Active - Recruiting

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240004

    Barcelona, Catalunya [Cataluña] 08025
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240005

    Seville, Sevilla 41013
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240002

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240003

    Valencia, 46026
    Spain

    Active - Recruiting

  • Investigational Site Number : 1580001

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Investigational Site Number : 1580002

    Taipei City, 100
    Taiwan

    Active - Recruiting

  • Investigational Site Number : 8260004

    Salford, Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8260005

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8400012

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Investigational Site Number : 8400014

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital Arkes Pavilion- Site Number : 8400014

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Investigational Site Number : 8400010

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Investigational Site Number : 8400019

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Investigational Site Number : 8400001

    New York, New York 10032
    United States

    Active - Recruiting

  • Investigational Site Number : 8400005

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Investigational Site Number: 8400016

    Houston, Texas 77054
    United States

    Active - Recruiting

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