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

Phase 2

• Conditions: IgAN; Lupus Nephritis; C3 Glomerulopathy; MN
• Interventions: Biological: OMS721 (narsoplimab)

• Registration Number: NCT02682407
• Lead Sponsor: Omeros Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OMS721 (narsoplimab)	OMS721 (narsoplimab)	Administration of OMS721 (narsoplimab)

Primary Outcome Measures

Name	Time	Method
Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.	38 weeks
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).	up to 104 weeks
Cohort 4: Change from baseline in serum and urine complement component levels.	38 weeks

Secondary Outcome Measures

Name	Time	Method
Cohort1-3: Change from baseline in proteinuria.	up to 104 weeks
Cohort 4: Change from baseline in serum narsoplimab concentrations.	38 weeks
Cohort 1-3: Change from baseline in serum narsoplimab concentrations.	up to 104 weeks
Cohort1-3: Change from baseline in urine albumin/creatinine ratio.	up to 104 weeks

Trial Locations

Locations (1)

Omeros Investigational Site; 🇭🇰 Sha Tin, Hong Kong