The Discovery Trial for IgAN, MN, LN, and C3G Patients
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)
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
Trial Physician / Study Coordinator
Federico Grossi, MD, PhD
Email Phone 617-977-5717Site Name
Apellis Investigational Site
The Discovery Trial for IgAN, MN, LN, and C3G Patients
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)
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
Eligibility Criteria
Patient Population
Primary Membranous Nephropathy (MN), IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G)
About the Drug
What is involved for the patient
Patients will be involved in the study for 16 weeks, and will take the study drug as a daily subcutaneous injection.
Sponsor
Apellis Pharmaceuticals, Inc.
Target Enrollment
48
Estimated End Date
October, 2019
About the Trial
Study Drug
APL-2
Study Goal
To determine if APL-2 can cause a reduction of proteinuria in patients with IgAN, C3G, or MN.
About the drug or intervention
APL-2 is a C3 complement mediator administered as daily subcutaneous infusions.