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

Purpose

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

Eligibility

Eligible Ages
Between 16 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Frexalimab 		Frexalimab active dose
  • Drug: frexalimab
    frexalimab treatment
Experimental
Brivekimig 		Brivekimig active dose
  • Drug: brivekimig
    brivekimig treatment
Experimental
Rilzabrutinib 		Rilzabrutinib active dose
  • Drug: rilzabrutinib
    rilzabrutinib treatment
Placebo Comparator
Placebo 		Matching placebo
  • Drug: placebo
    placebo treatment

Recruiting Locations

Investigational Site Number : 8400007
Birmingham, Alabama 35233

Investigational Site Number : 8400015
Orange, California 92868

Investigational Site Number : 8400012
San Francisco, California 94143

Investigational Site Number : 8400025
Tampa, Florida 33612

Emory Children's Center- Site Number : 8400020
Atlanta, Georgia 30322

Investigational Site Number : 8400014
Chicago, Illinois 60611

Investigational Site Number : 8400017
Hinsdale, Illinois 60521

Investigational Site Number : 8400010
Ann Arbor, Michigan 48109

Investigational Site Number : 8400019
Edina, Minnesota 55435

Investigational Site Number : 8400018
Las Vegas, Nevada 89107

Investigational Site Number: 8400028
Albuquerque, New Mexico 87109

Investigational Site Number : 8400001
New York, New York 10032

Investigational Site Number : 8400021
Chapel Hill, North Carolina 27599

Investigational Site Number : 8400024
Dallas, Texas 75204

Investigational Site Number : 8400005
El Paso, Texas 79902

Investigational Site Number: 8400016
Houston, Texas 77054

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com