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Tests treatment safety and results for Focal Segmental Glomerulosclerosis
Official title 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
ClinicalTrials.gov ID: NCT06500702
What this study is testing
What is frexalimab?
frexalimab is an investigational medicine, being studied as a potential treatment for focal segmental glomerulosclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- 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...
- ≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
You likely can't join if
- 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...
See the full eligibility 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...
- ≤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 blinded 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 blinded or OLE treatment...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Orange, California, United States
- San Francisco, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Hinsdale, Illinois, United States
- Ann Arbor, Michigan, United States
- Edina, Minnesota, United States
- Las Vegas, Nevada, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Dallas, Texas, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- Buenos Aires, Argentina
- Córdoba, Argentina
- Garran, Australian Capital Territory, Australia
- Parkville, Victoria, Australia
+ 47 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Orange, California, United States; San Francisco, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 61 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.