* 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
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
You may not be if
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
Clareo Health | A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis
