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A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis
EU CTIS ID: 2025-524448-36-00
What this study is testing
Primary objective for Phase 2: To assess the efficacy of twice-weekly SC doses of pegcetacoplan in adult participants with FSGS on the basis of a reduction of proteinuria Primary objective for Phase 3: To assess the efficacy of twice-weekly SC doses of pegcetacoplan compared with placebo in participants with FSGS on the basis of a reduction of proteinuria
- Phase II and Phase III (Integrated)
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
- 1. Age - Phase 2: adults aged ≥18 years - Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form
- 2. Weight ≥30 kg and ≤100 kg at screening
- 3. FSGS diagnosis - Phase 2: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy - Phase 3: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy or by recognized podocyte genetic mutation"
- 4. At least 1.5 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g/g in at least 2 FMU samples collected during screening"
- 5. Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m^2
- 6. Stable regimen for FSGS treatment for at least 12 weeks prior to the first dose of IP with no planned or anticipated adjustments or dose changes to the stable treatment regimen"
You likely can't join if
- 1 Previous exposure to pegcetacoplan
- 2 Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
- 3 FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
- 4 Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
- 5 History of kidney transplant
- 6 Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses
See the full eligibility criteria
- 1. Age - Phase 2: adults aged ≥18 years - Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form
- 2. Weight ≥30 kg and ≤100 kg at screening
- 3. FSGS diagnosis - Phase 2: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy - Phase 3: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy or by recognized podocyte genetic mutation"
- 4. At least 1.5 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g/g in at least 2 FMU samples collected during screening"
- 5. Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m^2
- 6. Stable regimen for FSGS treatment for at least 12 weeks prior to the first dose of IP with no planned or anticipated adjustments or dose changes to the stable treatment regimen"
- 1 Previous exposure to pegcetacoplan
- 2 Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
- 3 FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
- 4 Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
- 5 History of kidney transplant
- 6 Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses
- 7 Hypersensitivity to pegcetacoplan or to any of the excipients
- 8 Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results
- 9 Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Switzerland
- Taiwan
- United States
- Australia
- Argentina
- 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, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Switzerland; Taiwan; United States; Australia; Argentina and 2 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.