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
Study of Investigational Medications for Kidney Conditions
Study 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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
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Age: 16 years - 75 years
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Gender: All
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.
This study investigates the effects of investigational medications on primary focal segmental glomerulosclerosis (FSGS) and primary minimal change disease (MCD). The purpose of this study is to compare how frexalimab, brivekimig, and rilzabrutinib affect protein levels in the urine and remission rates of nephrotic syndrome in participants aged 16 to 75 years.
Participants in the study will be randomly assigned to one of six study arms, including those receiving a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve various procedures, including regular monitoring of protein levels in urine and other health assessments to evaluate the safety and efficacy of the treatments.
- Who can participate: Individuals aged 16 to 75 years with a biopsy showing primary FSGS or MCD may participate. Key criteria include specific protein levels in the urine and kidney function.
- Study details: Participants will be assigned to one of six study arms, including a placebo group. They will receive treatment and undergo regular assessments to monitor their condition and response to the investigational medications.
- Study timelines and visits: The study will last 76 weeks. The study requires 18 visits.
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