Clinical trial NCT06500702: 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
Official title: A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Focal Segmental Glomerulosclerosis
Glomerulonephritis Minimal Lesion
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Percent reduction in urine protein to creatinine ratio (UPCR)
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: Percentage of participants achieving FSGS partial remission endpoint
timeFrame: At Week 12
measure: Percentage of participants achieving CR
timeFrame: At Week 12
measure: 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
timeFrame: Treatment emergent period, up to Week 48
measure: Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970
timeFrame: Up to Week 48
measure: Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970
timeFrame: Up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number : 8400007
state: Alabama
city: Orange
country: United States
facility: Investigational Site Number : 8400015
state: California
city: San Francisco
country: United States
facility: Investigational Site Number : 8400012
state: California
city: Chicago
country: United States
facility: Investigational Site Number : 8400014
state: Illinois
city: Hinsdale
country: United States
facility: Investigational Site Number : 8400017
state: Illinois
city: Ann Arbor
country: United States
facility: Investigational Site Number : 8400010
state: Michigan
city: Edina
country: United States
facility: Investigational Site Number : 8400019
state: Minnesota
city: Las Vegas
country: United States
facility: Investigational Site Number : 8400018
state: Nevada
city: New York
country: United States
facility: Investigational Site Number : 8400001
state: New York
city: El Paso
country: United States
facility: Investigational Site Number : 8400005
state: Texas
city: Houston
country: United States
facility: Investigational Site Number: 8400016
state: Texas
city: Cordoba
country: Argentina
facility: Investigational Site Number : 0320002
state: Córdoba
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Parkville
country: Australia
facility: Investigational Site Number : 0360001
state: Victoria
city: Sao Paulo
country: Brazil
facility: Investigational Site Number : 0760002
state: São Paulo
city: São Paulo
country: Brazil
facility: Investigational Site Number : 0760001
city: Montreal
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Quebec City
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
city: Beijing
country: China
facility: Investigational Site Number : 1560001
city: Chengdu
country: China
facility: Investigational Site Number : 1560003
city: Shanghai
country: China
facility: Investigational Site Number : 1560004
city: Prague
country: Czechia
facility: Investigational Site Number : 2030001
city: Créteil
country: France
facility: Investigational Site Number : 2500002
city: Paris
country: France
facility: Investigational Site Number : 2500001
city: Berlin
country: Germany
facility: Investigational Site Number : 2760002
city: Hannover
country: Germany
facility: Investigational Site Number : 2760003
city: Athens
country: Greece
facility: Investigational Site Number : 3000002
city: Heraklion
country: Greece
facility: Investigational Site Number : 3000001
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480001
city: Florence
country: Italy
facility: Investigational Site Number : 3800002
state: Firenze
city: Naples
country: Italy
facility: Investigational Site Number : 3800003
state: Napoli
city: Brescia
country: Italy
facility: Investigational Site Number : 3800001
city: Amsterdam
country: Netherlands
facility: Investigational Site Number : 5280001
city: Opole
country: Poland
facility: Investigational Site Number : 6160002
city: Matosinhos
country: Portugal
facility: Investigational Site Number : 6200001
city: Porto
country: Portugal
facility: Investigational Site Number : 6200002
city: Martin
country: Slovakia
facility: Investigational Site Number : 7030001
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240004
state: Catalunya [Cataluña]
city: Seville
country: Spain
facility: Investigational Site Number : 7240005
state: Sevilla
city: Córdoba
country: Spain
facility: Investigational Site Number : 7240002
city: Valencia
country: Spain
facility: Investigational Site Number : 7240003
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580002
city: Salford
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Manchester
Study officials:
References: