A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
- Conditions
- Glomerulonephritis Minimal LesionFocal Segmental Glomerulosclerosis
- Interventions
- Registration Number
- NCT06500702
- Lead Sponsor
- Sanofi
- Brief Summary
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, SAR442970, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Biopsy-proven primary FSGS or primary MCD.
- UPCR ≥3 g/g at screening.
- eGFR ≥45 mL/min/1.73 m^2 at screening.
- Documented history of UPCR reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.
- ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
- On stable dose of RAAS inhibitors for ≥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 ≥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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Frexalimab frexalimab Frexalimab active dose SAR442970 SAR442970 SAR442970 active dose Rilzabrutinib rilzabrutinib Rilzabrutinib active dose Placebo placebo Matching placebo
- Primary Outcome Measures
Name Time Method Percent reduction in urine protein to creatinine ratio (UPCR) From baseline to Week 12
- Secondary Outcome Measures
Name Time Method Percentage of participants achieving FSGS partial remission endpoint At Week 12 Defined as UPCR ≤1.5 g/g and \>40 % reduction of UPCR from baseline
Percentage of participants achieving CR At Week 12 Defined as UPCR ≤0.3 g/g
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 Treatment emergent period, up to Week 48 TEAEs, including clinically significant changes in vital signs, electrocardiogram \[ECG\], and laboratory evaluation
Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970 Up to Week 48 Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970 Up to Week 48
Trial Locations
- Locations (39)
Investigational Site Number : 7240002
🇪🇸Córdoba, Spain
Investigational Site Number : 7240003
🇪🇸Valencia, Spain
Investigational Site Number : 8400015
🇺🇸Orange, California, United States
Investigational Site Number : 8400017
🇺🇸Hinsdale, Illinois, United States
Investigational Site Number : 8400018
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number : 8260004
🇬🇧Salford, Manchester, United Kingdom
Investigational Site Number : 8400012
🇺🇸San Francisco, California, United States
Investigational Site Number : 8400014
🇺🇸Chicago, Illinois, United States
Investigational Site Number : 8400010
🇺🇸Ann Arbor, Michigan, United States
Investigational Site Number : 8400019
🇺🇸Edina, Minnesota, United States
Investigational Site Number : 8400001
🇺🇸New York, New York, United States
Investigational Site Number : 8400005
🇺🇸El Paso, Texas, United States
Investigational Site Number: 8400016
🇺🇸Houston, Texas, United States
Investigational Site Number : 0320002
🇦🇷Cordoba, Córdoba, Argentina
Investigational Site Number : 0360001
🇦🇺Parkville, Victoria, Australia
Investigational Site Number : 0760001
🇧🇷São Paulo, Brazil
Investigational Site Number : 1240001
🇨🇦Montreal, Quebec, Canada
Investigational Site Number : 1240006
🇨🇦Quebec City, Quebec, Canada
Investigational Site Number : 1520002
🇨🇱Santiago, Chile
Investigational Site Number : 1560001
🇨🇳Beijing, China
Investigational Site Number : 1560003
🇨🇳Chengdu, China
Investigational Site Number : 1560004
🇨🇳Shanghai, China
Investigational Site Number : 2500002
🇫🇷Créteil, France
Investigational Site Number : 2500001
🇫🇷Paris, France
Investigational Site Number : 2760002
🇩🇪Berlin, Germany
Investigational Site Number : 2760003
🇩🇪Hannover, Germany
Investigational Site Number : 3000002
🇬🇷Athens, Greece
Investigational Site Number : 3000001
🇬🇷Heraklion, Greece
Investigational Site Number : 3800003
🇮🇹Naples, Napoli, Italy
Investigational Site Number : 3800001
🇮🇹Brescia, Italy
Investigational Site Number : 5280001
🇳🇱Amsterdam, Netherlands
Investigational Site Number : 6160002
🇵🇱Opole, Poland
Investigational Site Number : 6200001
🇵🇹Matosinhos, Portugal
Investigational Site Number : 6200002
🇵🇹Porto, Portugal
Investigational Site Number : 7240001
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240004
🇪🇸Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240005
🇪🇸Seville, Sevilla, Spain
Investigational Site Number : 1580001
🇨🇳Taichung, Taiwan
Investigational Site Number : 1580002
🇨🇳Taipei City, Taiwan