The purpose of this study was to evaluate the safety and tolerability of OMS721 (narsoplimab) in participants with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 Glomerulopathy (C3G) including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of narsoplimab when administered intravenously and when administered both intravenously and subcutaneously in participants of Asian descent with IgA Nephropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
Biological: narsoplimab
Omeros Investigational Site
Denver, Colorado, United States
Omeros Investigational Site
Augusta, Georgia, United States
Omeros Investigational Site
Lawrenceville, Georgia, United States
Omeros Investigational Site
Evergreen Park, Illinois, United States
Omeros Investigational Site
Voorhees Township, New Jersey, United States
Omeros Investigational Site
Flushing, New York, United States
Omeros Investigational Site
San Antonio, Texas, United States
Omeros Investigational Site
Milwaukee, Wisconsin, United States
Omeros Investigational Site
Chai Wan, Hong Kong
Omeros Investigational Site
Hong Kong, Hong Kong
...and 2 more locations
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).
Proportion of participants with Treatment Related Adverse Events (AE).
Time frame: up to 104 weeks
Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.
Proportion of participants with Treatment Related Adverse Events (AE).
Time frame: 38 weeks
Cohort 4: Change From Baseline in Serum and Urine Complement Component Levels.
Concentrations of urine complement components
Time frame: 38 weeks
Cohort 1-3: Absolute Change From Baseline in Serum Narsoplimab Concentrations (ng/mL).
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
Time frame: up to 104 weeks
Cohort 4: Change From Baseline in Serum Narsoplimab Concentrations.
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
Time frame: 38 weeks
Cohort 1-3: Change From Baseline in Urine Protein Excretion (UPE) mg/24hrs.
Change from Baseline in Urine Protein Excretion (UPE) in mg/24s up to Day 120
Time frame: up to 120 days
Cohort 1-3: Change From Baseline in Urine Albumin/Creatinine Ratio.
Change From Baseline in Urine Albumin/Creatinine Ratio (mg/g) in OMS721 subjects at Day 120. Data was displayed for up to 120 days, because some patients received retreatment afterwards.
Time frame: up to 104 weeks
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