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

Lupus Nephritis Clinical Trial

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 Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02682407
• Other study ID #: OMS721-GNP-001
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Omeros Corporation
• Contact: Omeros Clinical Trial Information
• Phone: 206-676-5000
• Email: ctinfo[@]omeros.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C3 Glomerulopathy
• Glomerulonephritis, Membranoproliferative
• IgAN
• Lupus Nephritis
• MN
• Nephritis

Intervention

Biological:
• OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)

Locations

Country	Name	City	State
Hong Kong	Omeros Investigational Site	Chai Wan
Hong Kong	Omeros Investigational Site	Hong Kong
Hong Kong	Omeros Investigational Site	Kowloon
Hong Kong	Omeros Investigational Site	Sha Tin
United States	Omeros Investigational Site	Augusta	Georgia
United States	Omeros Investigational Site	Denver	Colorado
United States	Omeros Investigational Site	Evergreen Park	Illinois
United States	Omeros Investigational Site	Flushing	New York
United States	Omeros Investigational Site	Lawrenceville	Georgia
United States	Omeros Investigational Site	Milwaukee	Wisconsin
United States	Omeros Investigational Site	San Antonio	Texas
United States	Omeros Investigational Site	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Omeros Corporation

Countries where clinical trial is conducted

United States,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).		up to 104 weeks
Primary	Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.		38 weeks
Primary	Cohort 4: Change from baseline in serum and urine complement component levels.		38 weeks
Secondary	Cohort 1-3: Change from baseline in serum narsoplimab concentrations.		up to 104 weeks
Secondary	Cohort 4: Change from baseline in serum narsoplimab concentrations.		38 weeks
Secondary	Cohort1-3: Change from baseline in proteinuria.		up to 104 weeks
Secondary	Cohort1-3: Change from baseline in urine albumin/creatinine ratio.		up to 104 weeks