Status:
NOT_YET_RECRUITING
A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis
Lead Sponsor:
Apellis Pharmaceuticals, Inc.
Conditions:
FSGS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a sequential phase 2/3 study to evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS. The initial phase 2 portion is a single-ar...
Eligibility Criteria
Inclusion
- 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
- Weight ≥30 kg and ≤100 kg at screening
- 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
- 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
- Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2
- Stable regimen for FSGS treatment for at least 12 weeks prior to randomization, with no planned or anticipated adjustments or dose changes to the stable treatment regimen
Exclusion
- Previous exposure to APL2
- Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
- FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
- Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
- History of kidney transplant
- 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
- Hypersensitivity to APL2 or to any of the excipients
- Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results
- Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT07213960
Start Date
December 1 2025
End Date
December 1 2029
Last Update
October 9 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigator Site 1
Chicago, Illinois, United States, 60643
2
Investigator Site 2
New York, New York, United States, 10032