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

March 10, 2026 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 was to evaluate the safety and tolerability of OMS721 (narsoplimab) in participants with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and Complement Component 3 Glomerulopathy (C3G) including Dense Deposit Disease. The study will also evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and neutralizing antibodies (NAb) of narsoplimab when administered intravenously and when administered both intravenously and subcutaneously in participants of Asian descent with IgA Nephropathy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

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

Study Locations

  • Hong Kong
      • Chai Wan, Hong Kong
        • Omeros Investigational Site
      • Hong Kong, Hong Kong
        • Omeros Investigational Site
      • Kowloon, Hong Kong
        • Omeros Investigational Site
      • Shatin, Hong Kong
        • Omeros Investigational Site
  • United States
    • Colorado
      • Denver, Colorado, United States, 80230
        • Omeros Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Omeros Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Omeros Investigational Site
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Omeros Investigational Site
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Omeros Investigational Site
    • New York
      • Flushing, New York, United States, 11355
        • Omeros Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78215
        • Omeros Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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

Description

Inclusion Criteria:

Participants may be included in the study only if they meet all of the following criteria:

  1. Have a diagnosis of one of the following:

    • IgAN diagnosed on kidney biopsy
    • Lupus nephritis diagnosed on kidney biopsy (Cohort 1 only)
    • Primary MN diagnosed on kidney biopsy (Cohort 1 only)
    • C3 glomerulopathy including Dense Deposit Disease diagnosed on kidney biopsy (Cohort 1 only)
    • Biopsy confirmed diagnosis of IgAN within 8 years of screening (Cohort 4 only).
  2. Have 24-hour urine protein > 1000 mg/24 hours.
  3. Are age >= 18 years at Screening Visit 1 and (for Cohort 4 only) are of Asian descent.
  4. Have documented history of 24-hour urine protein > 1 g within 6 months prior to Screening or Urine Protein Creatinine Ratio (uPCR) > 0.75 by spot urine at Screening (Cohort 4 only).
  5. Have an eGFR > 30 mL/min/1.73 m^2 calculated by the Chronic Kidney Disease Epidemiology (CKD-EPI) equation at Screening (Cohort 4).
  6. Are on physician-directed, stable, optimized treatment with ACEIs and/or ARBs and have a systolic BP of < 150 mmHg and a diastolic BP of < 90 mmHg at rest.
  7. If female, are either a) not of childbearing potential (i.e., surgically sterilized or postmenopausal for > 1 year), b) have a negative pregnancy test at Screening and baseline and if sexually active must agree to use 2 medically reliable forms of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4), or c) have a medically sterilized male partner. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception, or a barrier method.
  8. If male having heterosexual intercourse, are either a) not of reproductive potential or b) if sexually active must agree to use a medically reliable form of contraception throughout the study (all Cohorts) and for at least 12 weeks after the last dose of study drug, including possible extended treatments (Cohort 4). Acceptable methods of birth control include spermicide in combination with a barrier method, or subject's female partner is willing to use medically acceptable methods of birth control (intrauterine device, hormonal contraception, or a barrier method).

Exclusion Criteria:

  1. Have a known hypersensitivity to any constituent of the investigational product.
  2. Have a hemoglobin < 9.0 g/dL.
  3. Have a platelet count < 100,000/mm^3.
  4. Have an absolute neutrophil count < 500 cells/mm^3.
  5. Have an alanine aminotransferase or aspartate aminotransferase > 5.0 x the upper limit of normal.
  6. Have systemic manifestations of Henoch-Schonlein purpura (e.g., joint pain, gastrointestinal bleeding, abdominal pain) within 2 years prior to Screening Visit 1.
  7. Have used belimumab, eculizumab, or rituximab within 6 months of Screening Visit 1.
  8. Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), or cytotoxic drugs, for IgAN within 8 weeks prior to Screening. Treatment with immunosuppressants or cytotoxic drugs for IgAN is not allowed during the Run-In Period. Treatment with immunosuppressants are allowed if such treatment is for indications other than IgAN(Cohort 4 only).
  9. Have a history of renal transplant.
  10. History of human immunodeficiency virus, evidence of immune suppression, active hepatitis C virus (HCV) infection (participants with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), hepatitis B virus (HBV) infection (participants with positive HBsAg are excluded. For participants with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).
  11. Have any significant infection requiring antibiotic treatment at Screening Visit 1.
  12. 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 subject has been disease-free for >=5 years.
  13. Have an expectation of survival of less than 24 months.
  14. If female, are pregnant or breastfeeding.
  15. Have received any other investigational drug or device or experimental procedures within 30 days of Screening Visit 1.
  16. Are an employee of Omeros, the investigative site, a study staff member, or their immediate family member.
  17. Have any condition that the Investigator believes would put the subject at risk from participation.
  18. For participants in Cohort 4, have received systemic corticosteroids within 8 weeks prior to Screening. Treatment with systemic corticosteroids is not allowed during the Run-In period.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narsoplimab

Administration of Narsoplimab

Vehicle: 5% dextrose in water
Biological: OMS721 (narsoplimab)
Biological: narsoplimab
Other Names:
  • narsoplimab
Other: Vehicle
Drug: Vehicle (5% dextrose in water)
Biological: OMS721 (narsoplimab)
Biological: narsoplimab
Other Names:
  • narsoplimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).
Time Frame: up to 104 weeks
Proportion of participants with Treatment Related Adverse Events (AE).
up to 104 weeks
Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.
Time Frame: 38 weeks
Proportion of participants with Treatment Related Adverse Events (AE).
38 weeks
Cohort 4: Change From Baseline in Serum and Urine Complement Component Levels.
Time Frame: 38 weeks
Concentrations of urine complement components
38 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1-3: Absolute Change From Baseline in Serum Narsoplimab Concentrations (ng/mL).
Time Frame: up to 104 weeks
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
up to 104 weeks
Cohort 4: Change From Baseline in Serum Narsoplimab Concentrations.
Time Frame: 38 weeks
Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)
38 weeks
Cohort 1-3: Change From Baseline in Urine Protein Excretion (UPE) mg/24hrs.
Time Frame: up to 120 days
Change from Baseline in Urine Protein Excretion (UPE) in mg/24s up to Day 120
up to 120 days
Cohort 1-3: Change From Baseline in Urine Albumin/Creatinine Ratio.
Time Frame: up to 104 weeks
Change From Baseline in Urine Albumin/Creatinine Ratio (mg/g) in OMS721 subjects at Day 120. Data was displayed for up to 120 days, because some patients received retreatment afterwards.
up to 104 weeks

Collaborators and Investigators

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

Sponsor

Omeros Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 10, 2016

Primary Completion (Actual)

August 25, 2020

Study Completion (Actual)

August 25, 2020

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimated)

February 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMS721-GNP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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