A Phase 2 interventional study of frexalimab and brivekimig in Focal Segmental Glomerulosclerosis and Glomerulonephritis Minimal Lesion, sponsored by Sanofi. Recruiting at 79 sites in 22 countries. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or 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 MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 52 weeks. The treatment duration will be 24 weeks. There will be up to 16 visits.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
This study's planned enrollment of 84 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Browse Glomerulosclerosis, Focal Segmental studies →Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Frexalimab active dose
Drug: frexalimab
Brivekimig active dose
Drug: brivekimig
Rilzabrutinib active dose
Drug: rilzabrutinib
Matching placebo
Drug: placebo
frexalimab treatment
brivekimig treatment
rilzabrutinib treatment
placebo treatment
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
Not enrolling at this site — choose another above.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Started Dec 2024 (actual). Primary completion is estimated for Dec 2026, 24 months after the start.
Of 17 phase 2 interventional studies under Glomerulosclerosis, Focal Segmental, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 42. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Frexalimab · Brivekimig · Rilzabrutinib
Glomerulosclerosis, Focal Segmental →