A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease (RESULT)

  • STATUS
    Recruiting
  • End date
    Feb 16, 2028
  • participants needed
    84
  • sponsor
    Sanofi
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Updated on 20 June 2025
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Summary

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, SAR442970, 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.

Details
Condition Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Age 16years - 75years
Clinical Study IdentifierNCT06500702
SponsorSanofi
Last Modified on20 June 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Biopsy-proven primary FSGS or primary MCD
UPCR ≥3 g/g at screening
eGFR ≥45 mL/min/1.73 m^2 at screening
Documented history of UPCR reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g
≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization
On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors treatment will not be allowed during the double-blind or OLE treatment period
On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable); starting SGLT2 inhibitor treatment 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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