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NCT Number: NCT06500702

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

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.

Recruiting

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 0320001, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frexalimab

Drug

frexalimab treatment

Brivekimig

Drug

brivekimig treatment

Rilzabrutinib

Drug

rilzabrutinib treatment

Placebo

Drug

placebo treatment

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

    Time frame: At Week 12

    Defined as UPCR ≤1.5 g/g and >40 % reduction of UPCR from baseline

  2. Percentage of participants achieving CR

    Time frame: At Week 12

    Defined as UPCR ≤0.3 g/g

  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

    Time frame: Treatment emergent period, up to Week 48

    TEAEs, including clinically significant changes in vital signs, electrocardiogram [ECG], and laboratory evaluation

  4. Plasma concentrations of frexalimab and rilzabrutinib and serum concentrations of SAR442970

    Time frame: Up to Week 48

  5. Occurrence of anti-drug antibodies (ADAs) against frexalimab and SAR442970

    Time frame: Up to Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

Acronym: RESULT

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jul 15, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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