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)

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06500702Tipo: INTERVENTIONALInicio: 19 de dic de 2024Fin estimado: 16 de feb de 2028

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

frexalimab

frexalimab treatment

drug

brivekimig

brivekimig treatment

drug

rilzabrutinib

rilzabrutinib treatment

drug

placebo

placebo treatment

Ubicaciones

Investigational Site Number : 0320001

Buenos Aires, Argentina

RECRUITING

Investigational Site Number : 0320002

Córdoba, Argentina

RECRUITING

Patrocinadores

PrincipalSanofi

Contactos

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

contact-us@sanofi.com 800-633-1610

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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