NCT03453619

Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies

A Phase 2 Study to Evaluate the Safety and Biologic Activity of APL- 2 in Patients With IgA Nephropathy, Lupus Nephritis, Primary Membranous Nephropathy, or C3 Glomerulopathy (C3 Glomerulonephritis and Dense Deposit Disease)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies

Conditions

• IgA Nephropathy
• Lupus Nephritis
• Membranous Nephropathy
• C3 Glomerulonephritis
• Dense Deposit Disease

Interventions

Type	Name	Description
DRUG	APL-2	APL-2 administered as a daily subcutaneous infusion for 48 weeks

Timeline

• Start date: 2018-02-26
• Primary completion: 2020-04-16
• Completion: 2023-08-26
• First posted: 2018-03-05
• Last updated: 2025-02-13
• Results posted: 2025-02-13

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study