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 on Effects of Investigational Medications in 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 primary focal segmental glomerulosclerosis (FSGS) and primary minimal change disease (MCD). The purpose of this study is to evaluate how different investigational medications impact proteinuria and the remission rates of nephrotic syndrome in participants aged 16 to 75 years.
Participants in this study will be randomly assigned to one of six study arms, receiving either one of the investigational medications or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will involve various procedures to monitor the participants' health and the effects of the treatments.
- Who can participate: Participants aged 16 to 75 years with a biopsy report indicative of primary FSGS or primary MCD are eligible. Key factors include a UPCR of ≥3 g/g at screening or ≥1.5 g/g with eGFR ≥60, and a stable body weight between 45 to 120 kg.
- Study details: Participants will be assigned to one of six study arms to receive an investigational medication. The study will involve monitoring the change in proteinuria and health effects.
- Study timelines and visits: The study will last 76 weeks. The study requires 18 visits.
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