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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

ConditionsFocal Segmental GlomerulosclerosisGlomerulonephritis Minimal Lesion
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-75
SponsorSanofi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 m² 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).

Disqualifiers

Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.

Collapsing variant of FSGS.

ESKD requiring dialysis or transplantation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • frexalimab

    Drug

    frexalimab treatment

  • brivekimig

    Drug

    brivekimig treatment

  • rilzabrutinib

    Drug

    rilzabrutinib treatment

  • placebo

    Drug

    placebo treatment

Treatment groups

84 Participants
are divided into 4 treatment groups
Group A: FrexalimabExperimental treatment 1 intervention
Group B: BrivekimigExperimental treatment 1 intervention
Group C: RilzabrutinibExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent reduction in urine protein to creatinine ratio (UPCR)

Time frame
From baseline to Week 12

Secondary outcomes

1

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
2

Percentage of participants achieving CR

Defined as UPCR ≤0.3 g/g

Time frame
At Week 12
3

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
4

Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970

Time frame
Up to Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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