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

April 8, 2020 updated by: Omeros Corporation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Omeros Clinical Trial Information
  • Phone Number: 206-676-5000
  • Email: ctinfo@omeros.com

Study Locations

  • Hong Kong
      • Chai Wan, Hong Kong
        • Recruiting
        • Omeros Investigational Site
      • Hong Kong, Hong Kong
        • Recruiting
        • Omeros Investigational Site
      • Kowloon, Hong Kong
        • Not yet recruiting
        • Omeros Investigational Site
      • Sha Tin, Hong Kong
        • Recruiting
        • Omeros Investigational Site
  • United States
    • Colorado
      • Denver, Colorado, United States, 80230
        • Active, not recruiting
        • Omeros Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Active, not recruiting
        • Omeros Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Active, not recruiting
        • Omeros Investigational Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Active, not recruiting
        • Omeros Investigational Site
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Active, not recruiting
        • Omeros Investigational Site
    • New York
      • Flushing, New York, United States, 11355
        • Active, not recruiting
        • Omeros Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78215
        • Active, not recruiting
        • Omeros Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • Omeros Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OMS721 (narsoplimab)
Administration of OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)
Biological: OMS721 (narsoplimab)
Other Names:
  • narsoplimab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omeros Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMS721-GNP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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