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Recruiting Phase 2 NCT06500702

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

Phase 2 – studying effectiveness and dosage
Conditions: Focal Segmental Glomerulosclerosis Glomerulonephritis Minimal Lesion

Sponsor: Sanofi

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Biopsy report indicative of primary FSGS or primary 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. * 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. * 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.
Locations 21
Argentina (1)
Investigational Site Number : 0320001
Buenos Aires
Australia (1)
Investigational Site Number : 0360003
Garran , Australian Capital Territory
Brazil (1)
Investigational Site Number : 0760002
São Paulo
Canada (1)
Investigational Site Number : 1240002
London , Ontario
Chile (1)
Investigational Site Number : 1520003
Temuco , La Araucanía
China (1)
Investigational Site Number : 1560001
Beijing
Czech Republic (1)
Investigational Site Number : 2030002
Olomouc
France (1)
Investigational Site Number : 2500002
Créteil
Germany (1)
Investigational Site Number : 2760002
Berlin
Greece (1)
Investigational Site Number : 3000002
Athens
Hungary (1)
Investigational Site Number : 3480001
Budapest
Italy (1)
Investigational Site Number : 3800002
Florence , Firenze
Mexico (1)
Investigational Site Number : 4840005
Mexico City , Mexico City
Netherlands (1)
Investigational Site Number : 5280001
Amsterdam
Poland (1)
Investigational Site Number : 6160004
Poznan , Greater Poland Voivodeship
Slovakia (1)
Investigational Site Number : 7030003
Banská Bystrica
Spain (1)
Investigational Site Number : 7240001
Barcelona , Barcelona [Barcelona]
Taiwan (1)
Investigational Site Number : 1580001
Taichung
Turkey (1)
Investigational Site Number : 7920001
İzmit
United Kingdom (1)
Investigational Site Number : 8260001
Leicester , Leicestershire
United States (1)
Investigational Site Number : 8400007
Birmingham , Alabama
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
16 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
19.12.2024
Completion date
16.02.2028
Registry ID
NCT06500702
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.