Recruiting

Phase 2

Frexalimab, SAR442970, RilzabrutinibA 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

Sponsor:

Sanofi

Code:

NCT06500702

Conditions

Focal Segmental Glomerulosclerosis

Glomerulonephritis Minimal Lesion

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Interventions

frexalimab

brivekimig

rilzabrutinib

placebo

Study Details

Brief summary:

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.

Conditions

Focal Segmental Glomerulosclerosis

Glomerulonephritis Minimal Lesion

Study ID

NCT06500702

Start date

Dec 19, 2024

Status verified date

Oct, 2026

Completion date

Feb 16, 2028

Anticipated

Primary completion date

Dec 23, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 16 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Biopsy report indicative of primary FSGS or 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 mL/min/1.73 m2.
eGFR ≥45 mL/min/1.73 m\^2 at screening.
Documented history of UPCR or UACR (or 24-hour urine protein or 24-hour urine albumin) reduction by >40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g or equivalent for UACR (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein is used or equivalent for 24-hr urine albumin if 24-hour urine albumin 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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Frexalimab

Frexalimab active dose

experimental: Brivekimig

Brivekimig active dose

experimental: Rilzabrutinib

Rilzabrutinib active dose

placebo comparator: Placebo

Matching placebo

Interventions

frexalimab

frexalimab treatment

brivekimig

brivekimig treatment

rilzabrutinib

rilzabrutinib treatment

placebo

placebo treatment

Primary outcome measure

Percent reduction in urine protein to creatinine ratio (UPCR) [ Time Frame: From baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610 contact-us@sanofi.com

Locations

University of Alabama -The Kirklin Clinic- Site Number : 8400007

Recruiting

Birmingham, Alabama, United States, 35233

University of California Irvine Medical Center- Site Number : 8400015

Recruiting

Orange, California, United States, 92868

University of California San Francisco - Parnassus Heights- Site Number : 8400012

Recruiting

San Francisco, California, United States, 94143

University Of South Florida - Parent- Site Number : 8400025

Recruiting

Tampa, Florida, United States, 33612

Emory Children's Center- Site Number : 8400020

Recruiting

Atlanta, Georgia, United States, 30322

Northwestern Memorial Hospital- Site Number : 8400014

Recruiting

Chicago, Illinois, United States, 60611

Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017

Recruiting

Hinsdale, Illinois, United States, 60521

University of Michigan Health System - Ann Arbor- Site Number : 8400010

Recruiting

Ann Arbor, Michigan, United States, 48109

InterMed Consultants - Edina Clinic- Site Number : 8400019

Recruiting

Edina, Minnesota, United States, 55435

Renal Medicine Associates- Site Number : 8400028

Recruiting

Albuquerque, New Mexico, United States, 87109

Columbia University Irving Medical Center- Site Number : 8400001

Recruiting

New York, New York, United States, 10032

The Children's Hospital at Montefiore- Site Number : 8400027

Recruiting

The Bronx, New York, United States, 10467

UNC Kidney Center- Site Number : 8400021

Recruiting

Chapel Hill, North Carolina, United States, 27599

Cleveland Clinic - Cleveland- Site Number : 8400029

Recruiting

Cleveland, Ohio, United States, 44195

Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024

Recruiting

Dallas, Texas, United States, 75204

El Paso Kidney Specialists- Site Number : 8400005

Recruiting

El Paso, Texas, United States, 79902

Prolato Clinical Research Center- Site Number : 8400016

Recruiting

Houston, Texas, United States, 77054

Investigational Site Number : 1240002

Recruiting

London, Ontario, Canada, N6A 5A5

Investigational Site Number : 1240004

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Investigational Site Number : 1240001

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Investigational Site Number : 1240005

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Investigational Site Number : 1240006

Recruiting

Québec, Quebec, Canada, G1R 2J6

More Information

Sponsor

Sanofi

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.