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 APL2 in Adults and Adolescents With Focal Segmental Glomerulosclerosis

To evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS.

CT.gov Identifier
NCT07213960
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Apellis
Collaborator
N/A
Study Contact Information
+1 617 977 5700
Recruiting
Contact Us

Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
Pegcetacoplan
Genes
N/A
Study Dates
Feb 2026 - Oct 2029
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • * 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 Criteria:
  • * 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

Protocol Summary

To evaluate the efficacy and safety of twice-weekly subcutaneous (SC) infusions of APL2 in patients diagnosed with FSGS.

Study Locations

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