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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
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
frexalimab
frexalimab treatment
brivekimig
brivekimig treatment
rilzabrutinib
rilzabrutinib treatment
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