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IgANPhase 2NCT02682407

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

A Phase 2 study testing OMS721 (narsoplimab) in people with IgAN and LN, run by Omeros Corporation at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgAN, LN, MN
What is being tested?
OMS721 (narsoplimab)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
12 sitesin 2 countries
Study dates
10 Mar 2016to 25 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants may be included in the study only if they meet all of the following criteria:
  • 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)
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  • Biopsy confirmed diagnosis of IgAN within 8 years of screening (Cohort 4 only).
  • Have 24-hour urine protein > 1000 mg/24 hours.
  • Are age >= 18 years at Screening Visit 1 and (for Cohort 4 only) are of Asian descent.
  • 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).
  • Have an eGFR > 30 mL/min/1.73 m^2 calculated by the Chronic Kidney Disease Epidemiology (CKD-EPI) equation at Screening (Cohort 4).
  • 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.
  • 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.
  • 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).

Who cannot join

  • Have a known hypersensitivity to any constituent of the investigational product.
  • Have a hemoglobin < 9.0 g/dL.
  • Have a platelet count < 100,000/mm^3.
  • Have an absolute neutrophil count < 500 cells/mm^3.
  • Have an alanine aminotransferase or aspartate aminotransferase > 5.0 x the upper limit of normal.
  • Have systemic manifestations of Henoch-Schonlein purpura (e.g., joint pain, gastrointestinal bleeding, abdominal pain) within 2 years prior to Screening Visit 1.
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  • Have used belimumab, eculizumab, or rituximab within 6 months of Screening Visit 1.
  • 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).
  • Have a history of renal transplant.
  • 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).
  • Have any significant infection requiring antibiotic treatment at Screening Visit 1.
  • 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.
  • Have an expectation of survival of less than 24 months.
  • If female, are pregnant or breastfeeding.
  • Have received any other investigational drug or device or experimental procedures within 30 days of Screening Visit 1.
  • Are an employee of Omeros, the investigative site, a study staff member, or their immediate family member.
  • Have any condition that the Investigator believes would put the subject at risk from participation.
  • 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States8 sites

  • Omeros Investigational Site

    Augusta, Georgia, 30909

  • Omeros Investigational Site

    Denver, Colorado, 80230

  • Omeros Investigational Site

    Evergreen Park, Illinois, 60805

  • Omeros Investigational Site

    Flushing, New York, 11355

  • Omeros Investigational Site

    Lawrenceville, Georgia, 30046

  • Omeros Investigational Site

    Milwaukee, Wisconsin, 53226

  • Omeros Investigational Site

    San Antonio, Texas, 78215

  • Omeros Investigational Site

    Voorhees Township, New Jersey, 08043

Other trials in United States

Hong Kong4 sites

  • Omeros Investigational Site

    Chai Wan

  • Omeros Investigational Site

    Hong Kong

  • Omeros Investigational Site

    Kowloon

  • Omeros Investigational Site

    Shatin

Other trials in Hong Kong

About this study

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

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.

Conditions
IgAN, LN, MN, C3G
Being tested
OMS721 (narsoplimab)
Keywords
Immunoglobulin A Nephropathy, Lupus Nephritis, Membranous Nephropathy, Complement Component 3 Glomerulopathy
Medical subject headings
Glomerulonephritis, IGA, Lupus Nephritis, Glomerulonephritis, Membranous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMS721 (narsoplimab)Biological

    Also called narsoplimab

    Biological: narsoplimab

Study groups in NCT02682407
Study groupRoleWhat they receive
NarsoplimabExperimentalAdministration of Narsoplimab Vehicle: 5% dextrose in water
Receives: Biological: OMS721 (narsoplimab)
VehicleOtherDrug: Vehicle (5% dextrose in water)
Receives: Biological: OMS721 (narsoplimab)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE).

    Proportion of participants with Treatment Related Adverse Events (AE).

    Measured: up to 104 weeks

  2. Cohort 4: Proportion of IgAN Participants of Asian Descent With Treatment Related AEs.

    Proportion of participants with Treatment Related Adverse Events (AE).

    Measured: 38 weeks

  3. Cohort 4: Change From Baseline in Serum and Urine Complement Component Levels.

    Concentrations of urine complement components

    Measured: 38 weeks

Secondary outcomes (4)

  1. Cohort 1-3: Absolute Change From Baseline in Serum Narsoplimab Concentrations (ng/mL).

    Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)

    Measured: up to 104 weeks

  2. Cohort 4: Change From Baseline in Serum Narsoplimab Concentrations.

    Pharmacokinetics (PK): Maximum plasma concentrations (Cmax)

    Measured: 38 weeks

  3. Cohort 1-3: Change From Baseline in Urine Protein Excretion (UPE) mg/24hrs.

    Change from Baseline in Urine Protein Excretion (UPE) in mg/24s up to Day 120

    Measured: up to 120 days

  4. Cohort 1-3: Change From Baseline in Urine Albumin/Creatinine Ratio.

    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.

    Measured: up to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2016 (estimated)
  2. Study start10 Mar 2016
  3. Primary completion25 Aug 2020
  4. Study completion25 Aug 2020

Why it stopped: Study terminated by Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Double blind vehicle controlled interventional study with open label period (Cohort 2 and 3) and strictly open-label studies (Cohort 1 and 4) Cohort 2 and 3 subjects were randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 studies were both open-label studies.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02682407
Sponsor's protocol ID
OMS721-GNP-001
Status last verified
Mar 2026
First submitted
10 Feb 2016
Last updated
30 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Lafayette RA, Rovin BH, Reich HN, Tumlin JA, Floege J, Barratt J. Safety, Tolerability and Efficacy of Narsoplimab, a Novel MASP-2 Inhibitor for the Treatment of IgA Nephropathy. Kidney Int Rep. 2020 Aug 13;5(11):2032-2041. doi: 10.1016/j.ekir.2020.08.003. eCollection 2020 Nov.

    PubMed 33163724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMS721 (narsoplimab) in people with IgAN and LN, run by Omeros Corporation at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE). (time frame: up to 104 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02682407, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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