Part of Clinical Trial Concierge Program

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

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. To evaluate the efficacy of frexalimab, brivekimig and rilzabrutinib on reduction in proteinuria compared to placebo in participants with primary FSGS/MCD

CT.gov Identifier
NCT06500702
EudraCT Identifier
N/A
CTIS:
2024-511775-15-00
Sponsor
Sanofi
Collaborator
N/A
Study Contact Information
+ 33 1 53 77 40 00
Recruiting
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Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
Rilzabrutinib
See More
Frexalimab
Brivekimig
Genes
N/A
Study Dates
Dec 2024 - Dec 2026
Sex
Female & Male
Age
16 - 75 Years
Inclusion and Exclusion Criteria
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.

Protocol 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, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.

To evaluate the efficacy of frexalimab, brivekimig and rilzabrutinib on reduction in proteinuria compared to placebo in participants with primary FSGS/MCD

Study Locations

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