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
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
Interventions
frexalimab
brivekimig
rilzabrutinib
placebo
Conditions
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