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RECRUITING
NCT06500702
PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

16 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2024-12-19

Completion Date

2028-02-16

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

frexalimab

frexalimab treatment

DRUG

brivekimig

brivekimig treatment

DRUG

rilzabrutinib

rilzabrutinib treatment

DRUG

placebo

placebo treatment

Locations (69)

Investigational Site Number : 8400007

Birmingham, Alabama, United States

Investigational Site Number : 8400015

Orange, California, United States

Investigational Site Number : 8400012

San Francisco, California, United States

Investigational Site Number : 8400025

Tampa, Florida, United States

Investigational Site Number : 8400014

Chicago, Illinois, United States

Investigational Site Number : 8400017

Hinsdale, Illinois, United States

Investigational Site Number : 8400010

Ann Arbor, Michigan, United States

Investigational Site Number : 8400019

Edina, Minnesota, United States

Investigational Site Number : 8400018

Las Vegas, Nevada, United States

Investigational Site Number: 8400028

Albuquerque, New Mexico, United States

Investigational Site Number : 8400001

New York, New York, United States

Investigational Site Number : 8400021

Chapel Hill, North Carolina, United States

Investigational Site Number : 8400024

Dallas, Texas, United States

Investigational Site Number : 8400005

El Paso, Texas, United States

Investigational Site Number: 8400016

Houston, Texas, United States

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320002

Córdoba, Argentina

Investigational Site Number : 0360003

Garran, Australian Capital Territory, Australia

Investigational Site Number : 0360001

Parkville, Victoria, Australia

Investigational Site Number : 0760002

São Paulo, Brazil

Investigational Site Number : 0760001

São Paulo, Brazil

Investigational Site Number : 1240002

London, Ontario, Canada

Investigational Site Number : 1240001

Montreal, Quebec, Canada

Investigational Site Number : 1240005

Montreal, Quebec, Canada

Investigational Site Number : 1240006

Québec, Quebec, Canada

Investigational Site Number : 1520003

Temuco, La Araucanía, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560001

Beijing, China

Investigational Site Number : 1560003

Chengdu, China

Investigational Site Number : 1560004

Shanghai, China

Investigational Site Number : 2030002

Olomouc, Czechia

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 2500002

Créteil, France

Investigational Site Number : 2500001

Paris, France

Investigational Site Number : 2760002

Berlin, Germany

Investigational Site Number : 2760003

Hanover, Germany

Investigational Site Number : 3000002

Athens, Greece

Investigational Site Number : 3000001

Heraklion, Greece

Investigational Site Number : 3000003

Ioannina, Greece

Investigational Site Number : 3480001

Budapest, Hungary

Investigational Site Number : 3800002

Florence, Firenze, Italy

Investigational Site Number : 3800003

Naples, Napoli, Italy

Investigational Site Number : 3800001

Brescia, Italy

Investigational Site Number : 4840005

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840001

Mexico City, Mexico City, Mexico

Investigational Site Number : 4840003

Monterrey, Nuevo León, Mexico

Investigational Site Number : 5280001

Amsterdam, Netherlands

Investigational Site Number : 6160004

Poznan, Greater Poland Voivodeship, Poland

Investigational Site Number : 6160001

Lodz, Lódzkie, Poland

Investigational Site Number : 6160002

Opole, Opole Voivodeship, Poland

Investigational Site Number : 6200003

Lisbon, Portugal

Investigational Site Number : 6200002

Porto, Portugal

Investigational Site Number : 7030003

Banská Bystrica, Slovakia

Investigational Site Number : 7030004

Bratislava, Slovakia

Investigational Site Number : 7030001

Martin, Slovakia

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240004

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240005

Seville, Sevilla, Spain

Investigational Site Number : 7240002

Córdoba, Spain

Investigational Site Number : 7240008

Madrid, Spain

Investigational Site Number : 7240007

Madrid, Spain

Investigational Site Number : 7240003

Valencia, Spain

Investigational Site Number : 1580001

Taichung, Taiwan

Investigational Site Number : 1580002

Taipei, Taiwan

Investigational Site Number : 7920001

İzmit, Turkey (Türkiye)

Investigational Site Number : 7920002

Kayseri, Turkey (Türkiye)

Investigational Site Number : 8260001

Leicester, Leicestershire, United Kingdom

Investigational Site Number : 8260004

Salford, Manchester, United Kingdom

Investigational Site Number : 8260005

Oxford, Oxfordshire, United Kingdom