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NCT06500702PHASE2Recruiting

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

Start Date

12/19/2024

Completion Date

2/16/2028

Summary

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.

Eligibility Criteria

Age Range: 16 years to 75 years

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.

Interventions

DRUG

frexalimab

DRUG

brivekimig

DRUG

rilzabrutinib

DRUG

placebo

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Conditions

Focal Segmental GlomerulosclerosisGlomerulonephritis Minimal Lesion

Locations

Investigational Site Number : 8400007

Birmingham, Alabama 35233

United States

Investigational Site Number : 8400015

Orange, California 92868

United States

Investigational Site Number : 8400012

San Francisco, California 94143

United States

Investigational Site Number : 8400025

Tampa, Florida 33612

United States

Emory Children's Center- Site Number : 8400020

Atlanta, Georgia 30322

United States

Investigational Site Number : 8400014

Chicago, Illinois 60611

United States

Investigational Site Number : 8400017

Hinsdale, Illinois 60521

United States

Investigational Site Number : 8400010

Ann Arbor, Michigan 48109

United States

Investigational Site Number : 8400019

Edina, Minnesota 55435

United States

Investigational Site Number : 8400018

Las Vegas, Nevada 89107

United States

Investigational Site Number: 8400028

Albuquerque, New Mexico 87109

United States

Investigational Site Number : 8400001

New York, New York 10032

United States

Investigational Site Number : 8400021

Chapel Hill, North Carolina 27599

United States

Investigational Site Number : 8400024

Dallas, Texas 75204

United States

Investigational Site Number : 8400005

El Paso, Texas 79902

United States

Investigational Site Number: 8400016

Houston, Texas 77054

United States

Investigational Site Number : 0320001

Buenos Aires, 1431

Argentina

Investigational Site Number : 0320002

Córdoba, 5016

Argentina

Investigational Site Number : 0360003

Garran, Australian Capital Territory 2605

Australia

Investigational Site Number : 0360001

Parkville, Victoria 3050

Australia

Investigational Site Number: 0760004

Botucatu, São Paulo 18618-970

Brazil

Synvia Clinical- Site Number : 0760005

São Paulo, São Paulo 01139-000

Brazil

Investigational Site Number : 0760002

São Paulo, 04038-002

Brazil

Investigational Site Number : 0760001

São Paulo, 05403-000

Brazil

Investigational Site Number : 1240002

London, Ontario N6A 5A5

Canada

Investigational Site Number : 1240001

Montreal, Quebec H1T 2M4

Canada

Investigational Site Number : 1240005

Montreal, Quebec H3T 1C5

Canada

Investigational Site Number : 1240006

Québec, Quebec G1R 2J6

Canada

Investigational Site Number : 1520003

Temuco, La Araucanía 4781151

Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago 8330034

Chile

Investigational Site Number : 1560001

Beijing, 100034

China

Investigational Site Number : 1560003

Chengdu, 610072

China

Investigational Site Number : 1560004

Shanghai, 200080

China

Investigational Site Number : 2030002

Olomouc, 779 00

Czechia

Investigational Site Number : 2030001

Prague, 128 08

Czechia

Investigational Site Number : 2500002

Créteil, 94010

France

Investigational Site Number : 2500001

Paris, 75015

France

Investigational Site Number : 2760002

Berlin, 10117

Germany

Investigational Site Number : 2760006

Dresden, 01307

Germany

Investigational Site Number : 2760003

Hanover, 30625

Germany

Investigational Site Number : 3000002

Athens, 115 27

Greece

Investigational Site Number : 3000001

Heraklion, 711 10

Greece

Investigational Site Number : 3000003

Ioannina, 455 00

Greece

Investigational Site Number : 3480001

Budapest, 1085

Hungary

Investigational Site Number : 3800002

Florence, Firenze 50134

Italy

Investigational Site Number : 3800003

Naples, Napoli 80131

Italy

Investigational Site Number : 3800001

Brescia, 25123

Italy

Investigational Site Number : 4840005

Mexico City, Mexico City 06720

Mexico

Investigational Site Number : 4840001

Mexico City, Mexico City 14080

Mexico

Investigational Site Number : 4840003

Monterrey, Nuevo León 64460

Mexico

Investigational Site Number : 5280001

Amsterdam, 1105 AZ

Netherlands

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship 60-780

Poland

Investigational Site Number : 6160001

Lodz, Lódzkie 02-213

Poland

Investigational Site Number : 6160002

Opole, Opole Voivodeship 45-418

Poland

Investigational Site Number : 6200003

Lisbon, 1050-099

Portugal

Investigational Site Number : 6200002

Porto, 4434-502

Portugal

Investigational Site Number : 7030003

Banská Bystrica, 975 17

Slovakia

Investigational Site Number : 7030004

Bratislava - Kramare, 831 01

Slovakia

Investigational Site Number : 7030001

Martin, 036 01

Slovakia

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona] 08035

Spain

Investigational Site Number : 7240005

Seville, Sevilla 41013

Spain

Investigational Site Number : 7240002

Córdoba, 14004

Spain

Investigational Site Number : 7240008

Madrid, 28007

Spain

Investigational Site Number : 7240007

Madrid, 28040

Spain

Investigational Site Number : 1580001

Taichung, 404

Taiwan

Investigational Site Number : 1580002

Taipei, 100

Taiwan

Investigational Site Number : 7920001

İzmit, 41001

Turkey (Türkiye)

Investigational Site Number : 7920002

Kayseri, 38039

Turkey (Türkiye)

Investigational Site Number : 8260001

Leicester, Leicestershire LE5 4PW

United Kingdom

Investigational Site Number : 8260004

Salford, Manchester M6 8HD

United Kingdom

Investigational Site Number : 8260005

Oxford, Oxfordshire OX3 7LE

United Kingdom