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

Omeros

Status and phase

Unknown

Phase 2

Conditions

C3 Glomerulopathy

Lupus Nephritis

IgAN

Treatments

Biological: OMS721 (narsoplimab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682407

OMS721-GNP-001

Details and patient eligibility

About

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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

At least 18 years of age at screening and competent to provide informed consent; For Cohort 4 only, participants are of Asian descent
Have a diagnosis of one of the following:
1. IgAN on kidney biopsy
2. LN, MN and C3 Glomerulopathy including Dense Deposit Disease on kidney biopsy and 24-hour Urine Protein Excretion (UPE) > 1000 mg/24 hours (for Cohort 1 only)
3. IgAN diagnosis is confirmed by biopsy within 8 years of screening for Asian descent (for Cohort 4 only)
For Cohort 4 only: subjects with IgAN of Asian descent, documented history of 24-hour UPE > 1 g within 6 months prior to Screening or Urine Protein-Creatinine Ratio (uPCR) > 0.75 by spot urine at screening
Screening Estimated Glomerular Filtration Rate (eGFR) >= 30 mL/min/1.73 m^2
Are on physician-directed, stable, optimized treatment with angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) and have a systolic blood pressure of < 150 mmHg and a diastolic blood pressure of < 90 mmHg at rest

Exclusion criteria

Have a hemoglobin less than 9.0 g/dL
Have a platelet count =less than 100,000/mm^3
Have an absolute neutrophil count <500 cells/mm^3
Have an Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) greater than 5.0 x the upper limit of normal (ULN)
Have systemic manifestations of Henoch-Schonlein purpura within 2 years prior to Screening
Have used: belimumab, eculizumab, or rituximab within 6 months prior to Screening
Have a history of renal transplant
History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (subjects with positive anti-HCV antibody
Have a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for 5 years or more