Evaluating treatments for kidney diseases in young to middle-aged adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a clinical trial is designed to assess the efficacy and safety of three treatments—frexalimab, SAR442970, and rilzabrutinib—compared to a placebo in participants aged 16 to 75 years with primary focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD). The study will measure changes in proteinuria and the rates of remission of nephrotic syndrome over a treatment duration of 24 weeks, with a total study duration of up to 76 weeks and up to 18 visits for participants. The trial is double-blind and includes multiple arms to ensure robust data collection and analysis.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama -The Kirklin Clinic- Site Number : 8400007
  Birmingham, Alabama, United States Recruiting
• University of California Irvine Medical Center- Site Number : 8400015
  Orange, California, United States Recruiting
• University of California San Francisco - Parnassus Heights- Site Number : 8400012
  San Francisco, California, United States Recruiting
• University Of South Florida - Parent- Site Number : 8400025
  Tampa, Florida, United States Recruiting
• Emory Children's Center- Site Number : 8400020
  Atlanta, Georgia, United States Recruiting
• Northwestern Memorial Hospital- Site Number : 8400014
  Chicago, Illinois, United States Recruiting

+29 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.