BridgeMD
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
EU CTIS ID: 2024-511775-15-00
What this study is testing
To evaluate the efficacy of frexalimab, brivekimig and rilzabrutinib on reduction in proteinuria compared to placebo in participants with primary FSGS/MCD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Biopsy report indicative of primary FSGS or primary 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.
- eGFR ≥45 mL/min/1.73 m^2 at screening.
- Documented history of UPCR (or 24-hour urine protein) reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein 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.
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.
See the full eligibility criteria
- Biopsy report indicative of primary FSGS or primary 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.
- eGFR ≥45 mL/min/1.73 m^2 at screening.
- Documented history of UPCR (or 24-hour urine protein) reduction by ≥40% in response to corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urine protein 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.
- Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
- Collapsing variant of FSGS.
- ESKD requiring dialysis or transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Turkey
- Australia
- China
- Mexico
- Argentina
- Taiwan
- United States
- Chile
- United Kingdom
- Brazil
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Turkey; Australia; China; Mexico; Argentina and 5 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 EU CTIS; the study team decides eligibility.