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

Last updated: May 1, 2026
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Nephrotic Syndrome

Glomerulosclerosis

Kidney Disease

Treatment

SAR442970

brivekimig

placebo

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, brivekimig, 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 report indicative of primary FSGS or primary MCD, with supportive clinicalpresentation per Investigator's judgement.

  • UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60.

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

  • Documented history of UPCR (or 24-hour urine protein) reduction by >40% in responseto corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urineprotein is used).

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

  • For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeksprior to screening; starting RAAS inhibitors or changing the dose will not beallowed during the double-blind or OLE treatment period.

  • For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeksprior to screening; starting SGLT2 inhibitor treatment or changing the dose will notbe allowed during the double-blind or OLE 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): 5
Primary Treatment: SAR442970
Phase: 2
Study Start date:
December 19, 2024
Estimated Completion Date:
February 16, 2028

Connect with a study center

  • Investigational Site Number : 0320001

    CABA, Buenos Aires F.D. 3433955 C1425ASG
    Argentina

    Site Not Available

  • Investigational Site Number : 0320002

    Cordoba, Córdoba X5016KET
    Argentina

    Site Not Available

  • Investigational Site Number : 0320001

    Buenos Aires, 1431
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Buenos Aires 3435910, 1431
    Argentina

    Site Not Available

  • Investigational Site Number : 0320002

    Córdoba, 5016
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320002

    Córdoba 3860259, 5016
    Argentina

    Site Not Available

  • Investigational Site Number : 0360003

    Canberra, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Investigational Site Number : 0360003

    Garran, Australian Capital Territory 2605
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360003

    Garran 9973428, Australian Capital Territory 2177478 2605
    Australia

    Site Not Available

  • Investigational Site Number : 0360001

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360001

    Parkville 2153770, Victoria 2145234 3050
    Australia

    Site Not Available

  • Investigational Site Number: 0760004

    Botucatu, São Paulo 18618-970
    Brazil

    Active - Recruiting

  • Investigational Site Number : 0760002

    Sao Paulo, São Paulo 04038-002
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760001

    São Paulo 3448439, São Paulo 3448433 05403-010
    Brazil

    Active - Recruiting

  • Investigational Site Number : 0760001

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Investigational Site Number : 0760002

    São Paulo, 04038-002
    Brazil

    Active - Recruiting

  • Investigational Site Number: 0760001

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Hospital do Rim e Hipertensão- Site Number : 0760002

    São Paulo 3448439, 04038-002
    Brazil

    Active - Recruiting

  • Investigational Site Number : 0760001

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Investigational Site Number : 0760002

    São Paulo 3448439, 04038-002
    Brazil

    Site Not Available

  • Investigational Site Number: 0760001

    São Paulo 3448439, 05403-000
    Brazil

    Active - Recruiting

  • Investigational Site Number: 0760002

    São Paulo 3448439, 04038-002
    Brazil

    Active - Recruiting

  • Investigational Site Number : 1240002

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240002

    London 6058560, Ontario 6093943 N6A 5A5
    Canada

    Site Not Available

  • Investigational Site Number : 1240001

    Montreal, Quebec H1T 2M4
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240005

    Montreal, Quebec H3T 1C5
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240006

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

  • Investigational Site Number : 1240006

    Québec, Quebec G1R 2J6
    Canada

    Active - Recruiting

  • Investigational Site Number : 1240001

    Montreal 6077243, Quebec 6115047 H1T 2M4
    Canada

    Site Not Available

  • Investigational Site Number : 1240006

    Québec 6325494, Quebec 6115047 G1R 2J6
    Canada

    Site Not Available

  • Investigational Site Number : 1520003

    Temuco, La Araucanía 4781151
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520003

    Temuco 3870011, La Araucanía 4781151
    Chile

    Site Not Available

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago 8330034
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520002

    Santiago 3871336, Reg Metropolitana de Santiago 8330034
    Chile

    Site Not Available

  • Investigational Site Number : 1560001

    Beijing, 100034
    China

    Active - Recruiting

  • Investigational Site Number : 1560001

    Beijing 1816670, 100034
    China

    Site Not Available

  • Investigational Site Number : 1560003

    Chengdu, 610072
    China

    Active - Recruiting

  • Investigational Site Number : 1560003

    Chengdu 1815286, 610072
    China

    Site Not Available

  • Investigational Site Number : 1560004

    Shanghai, 200080
    China

    Active - Recruiting

  • Investigational Site Number : 1560004

    Shanghai 1796236, 200080
    China

    Site Not Available

  • Investigational Site Number : 2030002

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030002

    Olomouc 3069011, 779 00
    Czechia

    Site Not Available

  • Investigational Site Number : 2030001

    Prague, 128 08
    Czechia

    Active - Recruiting

  • Investigational Site Number : 2030001

    Prague 3067696, 128 08
    Czechia

    Site Not Available

  • Investigational Site Number : 2500002

    Créteil, 94010
    France

    Active - Recruiting

  • Investigational Site Number : 2500002

    Créteil 3022530, 94010
    France

    Site Not Available

  • Investigational Site Number : 2500001

    Paris, 75015
    France

    Active - Recruiting

  • Investigational Site Number : 2500001

    Paris 2988507, 75015
    France

    Site Not Available

  • Investigational Site Number : 2760002

    Berlin, 10117
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760002

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Investigational Site Number : 2760006

    Dresden, 01307
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760003

    Hannover, 30625
    Germany

    Site Not Available

  • Investigational Site Number : 2760003

    Hanover, 30625
    Germany

    Active - Recruiting

  • Investigational Site Number : 2760003

    Hanover 2910831, 30625
    Germany

    Site Not Available

  • Investigational Site Number : 3000002

    Athens, 115 27
    Greece

    Active - Recruiting

  • Investigational Site Number : 3000002

    Athens 264371, 115 27
    Greece

    Site Not Available

  • Investigational Site Number : 3000001

    Heraklion, 711 10
    Greece

    Active - Recruiting

  • Investigational Site Number : 3000001

    Heraklion 261745, 711 10
    Greece

    Site Not Available

  • Investigational Site Number : 3000001

    Heraklion Crete, 715 00
    Greece

    Site Not Available

  • Investigational Site Number : 3000003

    Ioannina, 455 00
    Greece

    Active - Recruiting

  • Investigational Site Number : 3000003

    Ioannina 261779, 455 00
    Greece

    Site Not Available

  • Investigational Site Number : 3480001

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Investigational Site Number : 3480001

    Budapest 3054643, 1085
    Hungary

    Site Not Available

  • Investigational Site Number : 3800002

    Florence, Firenze 50134
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800002

    Florence 3176959, Firenze 50134
    Italy

    Site Not Available

  • Investigational Site Number : 3800003

    Naples, Napoli 80131
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800003

    Naples 3172394, Napoli 80131
    Italy

    Site Not Available

  • Investigational Site Number : 3800001

    Brescia, 25123
    Italy

    Active - Recruiting

  • Investigational Site Number : 3800001

    Brescia 3181554, 25123
    Italy

    Site Not Available

  • Investigational Site Number : 4840001

    Mexico City, Mexico City 14080
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840005

    Mexico City, Mexico City 06720
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840001

    Mexico City 3530597, Mexico City 3527646 14080
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840005

    Mexico City 3530597, Mexico City 3527646 06720
    Mexico

    Site Not Available

  • Investigational Site Number : 4840003

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

  • Investigational Site Number : 4840003

    Monterrey 3995465, Nuevo León 3522542 64460
    Mexico

    Site Not Available

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Investigational Site Number : 5280001

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Investigational Site Number : 6160004

    Poznan, Greater Poland Voivodeship 60-780
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160001

    Lodz, Lódzkie 02-213
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160001

    Lodz 3093133, Lódzkie 02-213
    Poland

    Site Not Available

  • Investigational Site Number : 6160002

    Opole, Opole Voivodeship 45-418
    Poland

    Active - Recruiting

  • Investigational Site Number : 6160002

    Opole 3090048, Opole Voivodeship 3337495 45-418
    Poland

    Site Not Available

  • Investigational Site Number : 6200003

    Lisbon, 1050-099
    Portugal

    Active - Recruiting

  • Investigational Site Number : 6200003

    Lisbon 2267057, 1050-099
    Portugal

    Site Not Available

  • Investigational Site Number : 6200001

    Matosinhos, 4464-513
    Portugal

    Site Not Available

  • Investigational Site Number : 6200001

    Matosinhos Municipality, 4464-513
    Portugal

    Site Not Available

  • Investigational Site Number : 6200001

    Matosinhos Municipality 2737824, 4464-513
    Portugal

    Site Not Available

  • Investigational Site Number : 6200002

    Porto, 4434-502
    Portugal

    Active - Recruiting

  • Investigational Site Number : 6200002

    Porto 2735943, 4434-502
    Portugal

    Site Not Available

  • Investigational Site Number : 6200002

    Vila Nova Gaia, 4434-502
    Portugal

    Site Not Available

  • Investigational Site Number : 7030003

    Banská Bystrica, 975 17
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7030003

    Banská Bystrica 3061186, 975 17
    Slovakia

    Site Not Available

  • Investigational Site Number : 7030004

    Bratislava, 833 05
    Slovakia

    Site Not Available

  • Investigational Site Number : 7030004

    Bratislava 3060972, 833 05
    Slovakia

    Site Not Available

  • Investigational Site Number : 7030004

    Bratislava - Kramare, 831 01
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7030001

    Martin, 036 01
    Slovakia

    Active - Recruiting

  • Investigational Site Number : 7030001

    Martin 3058780, 036 01
    Slovakia

    Site Not Available

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Barcelona 3128760, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240004

    Barcelona, Catalunya [Cataluña] 08025
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240004

    Barcelona 3128760, Catalunya [Cataluña] 08025
    Spain

    Site Not Available

  • Investigational Site Number : 7240005

    Seville, Sevilla 41013
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240005

    Seville 2510911, Sevilla 41013
    Spain

    Site Not Available

  • Investigational Site Number : 7240002

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240002

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Investigational Site Number : 7240007

    Madrid, 28040
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240008

    Madrid, 28007
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240007

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240008

    Madrid 3117735, 28007
    Spain

    Site Not Available

  • Investigational Site Number : 7240003

    Valencia, 46026
    Spain

    Site Not Available

  • Investigational Site Number : 7240003

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Investigational Site Number : 1580001

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Investigational Site Number : 1580001

    Taichung 1668399, 404
    Taiwan

    Site Not Available

  • Investigational Site Number : 1580002

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Investigational Site Number : 1580002

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Investigational Site Number : 1580002

    Taipei City, 100
    Taiwan

    Site Not Available

  • Investigational Site Number : 7920001

    Izmit, 41001
    Turkey

    Site Not Available

  • Investigational Site Number : 7920002

    Kayseri, 38030
    Turkey

    Site Not Available

  • Investigational Site Number : 7920002

    Kayseri, 38039
    Turkey (Türkiye)

    Active - Recruiting

  • Investigational Site Number : 7920002

    Kayseri 308464, 38039
    Turkey (Türkiye)

    Site Not Available

  • Investigational Site Number : 7920001

    Kocaeli 306970, 41100
    Turkey (Türkiye)

    Site Not Available

  • Investigational Site Number : 7920001

    İzmit, 41001
    Turkey (Türkiye)

    Active - Recruiting

  • Investigational Site Number : 7920001

    İzmit 745028, 41001
    Turkey (Türkiye)

    Site Not Available

  • Investigational Site Number : 8260001

    Leicester, Leicestershire LE5 4PW
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260001

    Leicester 2644668, Leicestershire LE5 4PW
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8260004

    Salford, Manchester M6 8HD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260004

    Salford 2638671, Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8260005

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • Investigational Site Number : 8260005

    Oxford 2640729, Oxfordshire OX3 7LE
    United Kingdom

    Site Not Available

  • Investigational Site Number : 8400007

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Investigational Site Number: 8400007

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Investigational Site Number : 8400007

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • Investigational Site Number: 8400007

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

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

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • Investigational Site Number : 8400015

    Orange, California 92868
    United States

    Active - Recruiting

  • Investigational Site Number : 8400012

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Investigational Site Number : 8400015

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Investigational Site Number: 8400015

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

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

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Investigational Site Number : 8400012

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Investigational Site Number: 8400012

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

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

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Investigational Site Number : 8400025

    Tampa, Florida 33612
    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 : 8400017

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Investigational Site Number : 8400014

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Investigational Site Number: 8400014

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital- Site Number : 8400014

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • Investigational Site Number : 8400017

    Hinsdale 4896012, Illinois 4896861 60521
    United States

    Active - Recruiting

  • Investigational Site Number: 8400017

    Hinsdale 4896012, Illinois 4896861 60521
    United States

    Site Not Available

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

    Hinsdale 4896012, Illinois 4896861 60521
    United States

    Active - Recruiting

  • Investigational Site Number : 8400010

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Investigational Site Number : 8400010

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Investigational Site Number: 8400010

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

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

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Investigational Site Number : 8400019

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • InterMed Consultants - Edina Clinic- Site Number : 8400019

    Edina 5025264, Minnesota 5037779 55435
    United States

    Active - Recruiting

  • Investigational Site Number : 8400019

    Edina 5025264, Minnesota 5037779 55435
    United States

    Active - Recruiting

  • Investigational Site Number: 8400019

    Edina 5025264, Minnesota 5037779 55435
    United States

    Site Not Available

  • Investigational Site Number : 8400018

    Las Vegas, Nevada 89107
    United States

    Active - Recruiting

  • Investigational Site Number : 8400018

    Las Vegas 5506956, Nevada 5509151 89107
    United States

    Active - Recruiting

  • Investigational Site Number: 8400018

    Las Vegas 5506956, Nevada 5509151 89107
    United States

    Site Not Available

  • Investigational Site Number: 8400028

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Investigational Site Number: 8400028

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Investigational Site Number : 8400001

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center- Site Number : 8400001

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Investigational Site Number : 8400001

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Investigational Site Number: 8400001

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Investigational Site Number : 8400021

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Investigational Site Number : 8400021

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Investigational Site Number : 8400024

    Dallas, Texas 75204
    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

  • Investigational Site Number : 8400024

    Dallas 4684888, Texas 4736286 75204
    United States

    Site Not Available

  • Investigational Site Number: 8400024

    Dallas 4684888, Texas 4736286 75204
    United States

    Active - Recruiting

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

    Dallas 4684888, Texas 4736286 75204
    United States

    Active - Recruiting

  • Investigational Site Number : 8400005

    El Paso 5520993, Texas 4736286 79902
    United States

    Site Not Available

  • Investigational Site Number: 8400016

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Prolato Clinical Research Center- Site Number : 8400016

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

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