A Sequential Phase 2/3 Study of APL2 in Patients With Focal Segmental Glomerulosclerosis

Paused · Phase 2/Phase 3 · Has a placebo group

Conditions studied: FSGS

In brief

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-arm, open-label study in adults diagnosed with FSGS. Phase 2 will commence prior to randomizing for phase 3. The phase 3 portion of the study is a randomized, placebo-controlled, double-blinded, multicenter study in adults and adolescents diagnosed with FSGS.

Key facts

Study ID

NCT07213960

Run by

Apellis Pharmaceuticals, Inc.

People needed

270

Starts

2026-12-01

Expected to finish

2029-12-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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

Where it is running

• Investigator Site 1 — Chicago, Illinois, United States
• Investigator Site 2 — New York, New York, United States

Full record on ClinicalTrials.gov

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