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

Primary Purpose

IgAN, Lupus Nephritis, MN

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OMS721 (narsoplimab)
Sponsored by
Omeros Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgAN focused on measuring IgAN, Lupus Nephritis, MN, C3 Glomerulopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational Site
  • Omeros Investigational SiteRecruiting
  • Omeros Investigational SiteRecruiting
  • Omeros Investigational Site
  • Omeros Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMS721 (narsoplimab)

Arm Description

Administration of OMS721 (narsoplimab)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cohort 1-3: Change from baseline in serum narsoplimab concentrations.
Cohort 4: Change from baseline in serum narsoplimab concentrations.
Cohort1-3: Change from baseline in proteinuria.
Cohort1-3: Change from baseline in urine albumin/creatinine ratio.

Full Information

First Posted
February 10, 2016
Last Updated
April 8, 2020
Sponsor
Omeros Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02682407
Brief Title
Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omeros Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgAN, Lupus Nephritis, MN, C3 Glomerulopathy
Keywords
IgAN, Lupus Nephritis, MN, C3 Glomerulopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Cohort 2 and 3 subjects are randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 are non-randomized.
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OMS721 (narsoplimab)
Arm Type
Experimental
Arm Description
Administration of OMS721 (narsoplimab)
Intervention Type
Biological
Intervention Name(s)
OMS721 (narsoplimab)
Other Intervention Name(s)
narsoplimab
Intervention Description
Biological: OMS721 (narsoplimab)
Primary Outcome Measure Information:
Title
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).
Time Frame
up to 104 weeks
Title
Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.
Time Frame
38 weeks
Title
Cohort 4: Change from baseline in serum and urine complement component levels.
Time Frame
38 weeks
Secondary Outcome Measure Information:
Title
Cohort 1-3: Change from baseline in serum narsoplimab concentrations.
Time Frame
up to 104 weeks
Title
Cohort 4: Change from baseline in serum narsoplimab concentrations.
Time Frame
38 weeks
Title
Cohort1-3: Change from baseline in proteinuria.
Time Frame
up to 104 weeks
Title
Cohort1-3: Change from baseline in urine albumin/creatinine ratio.
Time Frame
up to 104 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: IgAN on kidney biopsy 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omeros Clinical Trial Information
Phone
206-676-5000
Email
ctinfo@omeros.com
Facility Information:
Facility Name
Omeros Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Omeros Investigational Site
City
Chai Wan
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Omeros Investigational Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Omeros Investigational Site
City
Kowloon
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Omeros Investigational Site
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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