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Clinical Trials in the UK / NCT06500702
Recruiting Phase 2

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

NCT06500702 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 2
Started
2024-12-19
Last updated
2026-07-20

Condition(s) studied

Focal Segmental GlomerulosclerosisGlomerulonephritis Minimal Lesion

Investigational drug(s) / intervention(s)

frexalimabbrivekimigrilzabrutinibplacebo

frexalimab: frexalimab treatment

brivekimig: brivekimig treatment

rilzabrutinib: rilzabrutinib treatment

placebo: placebo treatment

Study 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

Sex
ALL
Min age
16 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Biopsy report indicative of primary FSGS or 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 mL/min/1.73 m2. * eGFR ≥45 mL/min/1.73 m\^2 at screening. * Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by \>40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin 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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Investigational Site Number : 8400007 Birmingham Alabama Recruiting
Investigational Site Number : 8400015 Orange California Recruiting
Investigational Site Number : 8400012 San Francisco California Recruiting
Investigational Site Number : 8400025 Tampa Florida Recruiting
Emory Children's Center- Site Number : 8400020 Atlanta Georgia Recruiting
Investigational Site Number : 8400014 Chicago Illinois Recruiting
Investigational Site Number : 8400017 Hinsdale Illinois Recruiting
Investigational Site Number : 8400010 Ann Arbor Michigan Recruiting
Investigational Site Number : 8400019 Edina Minnesota Recruiting
Investigational Site Number : 8400018 Las Vegas Nevada Recruiting
Investigational Site Number: 8400028 Albuquerque New Mexico Recruiting
Investigational Site Number : 8400001 New York New York Recruiting
Investigational Site Number : 8400021 Chapel Hill North Carolina Recruiting
Investigational Site Number : 8400024 Dallas Texas Recruiting
Investigational Site Number : 8400005 El Paso Texas Recruiting
Investigational Site Number: 8400016 Houston Texas Recruiting
Investigational Site Number : 0320001 Buenos Aires Argentina Recruiting
Investigational Site Number : 0320002 Córdoba Argentina Recruiting
Investigational Site Number : 0360003 Garran Australian Capital Territory Recruiting
Investigational Site Number : 0360001 Parkville Victoria Recruiting
Investigational Site Number: 0760004 Botucatu São Paulo Recruiting
Synvia Clinical- Site Number : 0760005 São Paulo São Paulo Recruiting
Investigational Site Number : 0760002 São Paulo Brazil Recruiting
Investigational Site Number : 0760001 São Paulo Brazil Recruiting
Investigational Site Number : 1240002 London Ontario Recruiting
Investigational Site Number : 1240001 Montreal Quebec Recruiting
Investigational Site Number : 1240005 Montreal Quebec Recruiting
Investigational Site Number : 1240006 Québec Quebec Recruiting
Investigational Site Number : 1520003 Temuco La Araucanía Recruiting
Investigational Site Number : 1520002 Santiago Reg Metropolitana de Santiago Recruiting
Investigational Site Number : 1560001 Beijing China Recruiting
Investigational Site Number : 1560003 Chengdu China Recruiting
Investigational Site Number : 1560004 Shanghai China Recruiting
Investigational Site Number : 2030002 Olomouc Czechia Recruiting
Investigational Site Number : 2030001 Prague Czechia Recruiting
Investigational Site Number : 2500002 Créteil France Recruiting
Investigational Site Number : 2500001 Paris France Recruiting
Investigational Site Number : 2760002 Berlin Germany Recruiting
Investigational Site Number : 2760006 Dresden Germany Recruiting
Investigational Site Number : 2760003 Hanover Germany Recruiting

+ 31 more sites — see the full list on the official registry below.

More Sanofi trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06500702 on ClinicalTrials.gov ↗ ← All trials in the UK