At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- frexalimab (drug), brivekimig (drug), rilzabrutinib (drug), placebo (drug)
- How long the study runs
- Study runs about 38 months (dates as stated)
- About the drug or intervention
- frexalimab — drug: frexalimab treatment · brivekimig — drug: brivekimig treatment · rilzabrutinib — drug: rilzabrutinib treatment · placebo — drug: placebo treatment
- Patient visit burden
- "There will be up to 16 visits." (as stated by sponsor)
- Type of study
- Testing a treatment
- Ages
- 16 Years to 75 Years
- Who
- All
- Number of participants
- 84
- Started
- 2024-12-19
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for focal segmental glomerulosclerosis
- • Phase2 - 84 participants
- • 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)
Who can take part?
- • Ages 16 Years to 75 Years
- • Diagnosed with focal segmental glomerulosclerosis
Where?
- • Leicester - Investigational Site Number : 8260001
- • Salford - Investigational Site Number : 8260004
- • Oxford - Investigational Site Number : 8260005
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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.
- ✓≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.
- ✓Body weight within 45 to 120 kg (inclusive) at screening.
Who cannot take part
- ✗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...
See the full criteria
Where Is This Study? (3 UK sites)
Investigational Site Number : 8260001
Leicester LE5 4PW, United Kingdom
Investigational Site Number : 8260004
Salford M6 8HD, United Kingdom
Investigational Site Number : 8260005
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
