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 Study Drugs for Primary FSGS or Minimal Change Disease
Study Overview
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 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 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.
The purpose of this research study is to learn about the effects and safety of three investigational study drugs, compared with a placebo, in people ages 16 to 75 who have primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The study will look at changes in protein in the urine (proteinuria) and how this relates to remission of nephrotic syndrome.
Participants will receive either an investigational study drug or a placebo. A placebo looks like the investigational study drug but does not contain active medication.
Who can participate:
People ages 16 to 75 with primary FSGS or MCD may be able to participate if they:
- Have a kidney biopsy report that supports a diagnosis of primary FSGS or MCD
- Have high levels of protein in their urine
- Have kidney function above a minimum level
- Have had a past decrease in urine protein after treatment with corticosteroids or another immune-suppressing medicine
- Are taking a low dose of prednisone (or similar steroid) that has been stable for at least one week
- If taking certain kidney-protecting medicines (RAAS inhibitors) or SGLT2 inhibitors, have been on a stable dose for at least four weeks
- Weigh between 45 and 120 kg
Study timeline and visits:
Participation lasts up to 52 weeks. There will be up to 16 visits.
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