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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
frexalimab treatment
brivekimig treatment
rilzabrutinib treatment
placebo treatment
Investigational Site Number: 8400007
Birmingham, Alabama, United States
RECRUITINGInvestigational Site Number: 8400015
Orange, California, United States
RECRUITINGInvestigational Site Number: 8400012
San Francisco, California, United States
RECRUITINGInvestigational Site Number: 8400014
Chicago, Illinois, United States
Percent reduction in urine protein to creatinine ratio (UPCR)
Time frame: From baseline to Week 12
Percentage of participants achieving FSGS partial remission endpoint
Defined as UPCR ≤1.5 g/g and \>40 % reduction of UPCR from baseline
Time frame: At Week 12
Percentage of participants achieving CR
Defined as UPCR ≤0.3 g/g
Time frame: At Week 12
Incidence of treatment-emergent adverse events, treatment-emergent serious adverse events (SAEs), treatment-emergent adverse events of special interest (AESIs) and IMP discontinuation due to TEAEs during the study
TEAEs, including clinically significant changes in vital signs, electrocardiogram \[ECG\], and laboratory evaluation
Time frame: Treatment emergent period, up to Week 48
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
Time frame: Up to Week 48
Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
Time frame: Up to Week 48
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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Investigational Site Number: 8400017
Hinsdale, Illinois, United States
RECRUITINGInvestigational Site Number: 8400010
Ann Arbor, Michigan, United States
RECRUITINGInvestigational Site Number: 8400019
Edina, Minnesota, United States
RECRUITINGInvestigational Site Number: 8400018
Las Vegas, Nevada, United States
RECRUITINGInvestigational Site Number: 8400028
Albuquerque, New Mexico, United States
RECRUITINGInvestigational Site Number: 8400001
New York, New York, United States
RECRUITING...and 53 more locations