The purpose of this study is to evaluate the safety and tolerability of OMS721 (narsoplimab) in subjects with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 (C3) Glomerulopathy including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of OMS721 when administered intravenously and when administered both intravenously and subcutaneously in subjects of Asian descent with IgA Nephropathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Biological: OMS721 (narsoplimab)
Omeros Investigational Site
Denver, Colorado, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Augusta, Georgia, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Lawrenceville, Georgia, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Evergreen Park, Illinois, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Voorhees Township, New Jersey, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Flushing, New York, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
San Antonio, Texas, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Milwaukee, Wisconsin, United States
ACTIVE_NOT_RECRUITINGOmeros Investigational Site
Chai Wan, Hong Kong
RECRUITINGOmeros Investigational Site
Hong Kong, Hong Kong
RECRUITING...and 2 more locations
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).
Time frame: up to 104 weeks
Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.
Time frame: 38 weeks
Cohort 4: Change from baseline in serum and urine complement component levels.
Time frame: 38 weeks
Cohort 1-3: Change from baseline in serum narsoplimab concentrations.
Time frame: up to 104 weeks
Cohort 4: Change from baseline in serum narsoplimab concentrations.
Time frame: 38 weeks
Cohort1-3: Change from baseline in proteinuria.
Time frame: up to 104 weeks
Cohort1-3: Change from baseline in urine albumin/creatinine ratio.
Time frame: up to 104 weeks
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