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
NCT ID: NCT06500702
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-12-19
2028-02-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Frexalimab
Frexalimab active dose
frexalimab
frexalimab treatment
Brivekimig
Brivekimig active dose
brivekimig
brivekimig treatment
Rilzabrutinib
Rilzabrutinib active dose
rilzabrutinib
rilzabrutinib treatment
Placebo
Matching placebo
placebo
placebo treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
frexalimab
frexalimab treatment
brivekimig
brivekimig treatment
rilzabrutinib
rilzabrutinib treatment
placebo
placebo treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* UPCR ≥3 g/g at screening.
* eGFR ≥45 mL/min/1.73 m\^2 at screening.
* Documented history of UPCR (or 24-hour urine protein) reduction by \>40% in response to 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 urine protein is used).
* ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
* On stable dose of RAAS for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors or changing the dose will not be allowed during the double-blind or OLE treatment period.
* On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); 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
* 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.
16 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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: 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 : 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 : 4840001
Mexico City, Mexico City, Mexico
Investigational Site Number : 4840003
Monterrey, Nuevo León, Mexico
Investigational Site Number : 5280001
Amsterdam, , Netherlands
Investigational Site Number : 6160001
Lodz, Lódzkie, Poland
Investigational Site Number : 6160002
Opole, Opole Voivodeship, Poland
Investigational Site Number : 6200001
Matosinhos Municipality, , 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 : 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
References
Explore related publications, articles, or registry entries linked to this study.
Lin J, Radhakrishnan J. What Are Baskets, Umbrellas, and Platforms Doing in Nephrology Clinical Trials? J Am Soc Nephrol. 2025 Feb 3;36(8):1652-1654. doi: 10.1681/ASN.0000000648. No abstract available.
Related Links
Access external resources that provide additional context or updates about the study.
ACT18064 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511775-15
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1301-2676
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT18064
Identifier Type: -
Identifier Source: org_study_id