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Набира участници Фаза 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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Focal Segmental Glomerulosclerosis Glomerulonephritis Minimal Lesion

Спонсор: Sanofi

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 21
Argentina (1)
Investigational Site Number : 0320001
Buenos Aires
Австралия (1)
Investigational Site Number : 0360003
Garran , Australian Capital Territory
Бразилия (1)
Investigational Site Number : 0760002
São Paulo
Канада (1)
Investigational Site Number : 1240002
London , Ontario
Chile (1)
Investigational Site Number : 1520003
Temuco , La Araucanía
Китай (1)
Investigational Site Number : 1560001
Beijing
Чехия (1)
Investigational Site Number : 2030002
Olomouc
Франция (1)
Investigational Site Number : 2500002
Créteil
Германия (1)
Investigational Site Number : 2760002
Berlin
Гърция (1)
Investigational Site Number : 3000002
Athens
Унгария (1)
Investigational Site Number : 3480001
Budapest
Италия (1)
Investigational Site Number : 3800002
Florence , Firenze
Mexico (1)
Investigational Site Number : 4840005
Mexico City , Mexico City
Нидерландия (1)
Investigational Site Number : 5280001
Amsterdam
Полша (1)
Investigational Site Number : 6160004
Poznan , Greater Poland Voivodeship
Словакия (1)
Investigational Site Number : 7030003
Banská Bystrica
Испания (1)
Investigational Site Number : 7240001
Barcelona , Barcelona [Barcelona]
Taiwan (1)
Investigational Site Number : 1580001
Taichung
Турция (1)
Investigational Site Number : 7920001
İzmit
Великобритания (1)
Investigational Site Number : 8260001
Leicester , Leicestershire
САЩ (1)
Investigational Site Number : 8400007
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
19.12.2024
Крайна дата
16.02.2028
Регистрационен номер
NCT06500702
Източник
anzctr
Запитване за медицински туризъм

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