Last updated on February 2018

Safety Study of IgAN LN MN & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721


Brief description of study

The purpose of this study is to evaluate the safety and tolerability of OMS721 in subjects with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3 Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (Nab).

Detailed Study Description

This is a Phase 2, multicenter study of OMS721 in subjects with the following diseases: IgA Nephropathy (IgAN), Lupus Nephritis, Membranous Nephropathy (MN), or C3 Glomerulopathy, including Dense Deposit Disease. Three cohorts will be enrolled. Cohort 1 will be subjects with corticosteroid dependent IgAN, LN, MN, or C3 Glomerulopathy. Cohort 1 subjects will all receive OMS721 in an uncontrolled, open-label design. Cohort 2 and 3 will be subjects with IgA nephropathy who are not receiving corticosteroids. These cohorts will be randomized to receive either OMS721 treatment or D5W vehicle in a randomized double-blind design. Approximately 44 subjects will be enrolled (16 in Cohort 1, 10 in Cohort 2, and 18 in Cohort 3).

Clinical Study Identifier: NCT02682407

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