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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2 Study to Evaluate the Safety and Effect on Proteinuria of OMS721 in Subjects With IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, or C3 Glomerulopathy Including Dense Deposit Disea

Brief Summary: 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 Summary: 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. Two 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 will be subjects with IgA nephropathy who are not receiving corticosteroids. This cohort will be randomized to receive either OMS721 treatment or D5W vehicle in a randomized double-blind design. Approximately 26 subjects will be enrolled (16 in Cohort 1 and 10 in Cohort 2).
Sponsor: Omeros Corporation

Current Primary Outcome: Safety as assessed by the incidence of adverse events up until the last visit at Week 18. [ Time Frame: 18 weeks ]

Assess the safety and tolerability of OMS721 in steroid-dependent subjects with IgAN, lupus nephritis, MN, and C3G.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of the safety of OMS721 on laboratory measures. [ Time Frame: 18 weeks ]
    Safety as assessed by changes in laboratory measures.
  • Assess the effect of OMS721 on proteinuria. [ Time Frame: 18 weeks ]
    Proteinuria as assessed by urine albumin/creatine ratio.


Original Secondary Outcome:

  • Assessment of the safety of OMS721 on laboratory measures. [ Time Frame: 18 weeks ]
    Safety as assessed by changes in laboratory measures.
  • Assess the effect of OMS721 on proteinuria. [ Time Frame: 18 weeks ]
    Proteinuria as assessed by urine albumin/creatine ratio.
  • Assess the need for corticosteroid treatment to maintain stable renal function. [ Time Frame: 18 weeks ]
    Corticosteroid need of the equivalent of 10 mg prednisone or more.


Information By: Omeros Corporation

Dates:
Date Received: February 10, 2016
Date Started: February 2016
Date Completion: January 2018
Last Updated: March 3, 2017
Last Verified: January 2017