Status:
RECRUITING
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
Lead Sponsor:
Sanofi
Conditions:
Focal Segmental Glomerulosclerosis
Glomerulonephritis Minimal Lesion
Eligibility:
All Genders
16-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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 (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.
- On stable dose of RAAS for ≥4 weeks prior to screening (if applicable); starting RAAS inhibitors or changing the dose 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 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
- 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.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 16 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06500702
Start Date
December 19 2024
End Date
February 16 2028
Last Update
December 24 2025
Active Locations (63)
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1
Investigational Site Number: 8400007
Birmingham, Alabama, United States, 35233
2
Investigational Site Number: 8400015
Orange, California, United States, 92868
3
Investigational Site Number: 8400012
San Francisco, California, United States, 94143
4
Investigational Site Number: 8400014
Chicago, Illinois, United States, 60611