A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of frexalimab, amlitelimab, and rilzabrutnib in patients with primary focal segmental glomerulosclerosis or minimal change disease
Eligibility
You can join if...
Inclusion Criteria:
Biopsy-proven primary FSGS or primary MCD.
UPCR greater than or equal to 3 g/g at screening.
eGFR greater than or equal to 45 mL/min/1.73 m^2 at screening.
Documented history of UPCR reduction by greater than or equal to 40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was greater than or equal to 3.5 g/g.
Less than or equal to 10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
On stable dose of RAAS inhibitors for greater than or equal to 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 greater than or equal to 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 to a patient's potential participation in a clinical trial.