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

NCT02682407 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: OMS721-GNP-001
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 12

Brief 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. 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; MN; LN; C3G

Keywords

Immunoglobulin A Nephropathy; Lupus Nephritis; Membranous Nephropathy; Complement Component 3 Glomerulopathy

Outcome Measures

Primary Outcomes (3)

• 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).

  up to 104 weeks

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

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

  38 weeks

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

  Concentrations of urine complement components

  38 weeks

Secondary Outcomes (4)

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

  up to 104 weeks

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

  38 weeks

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

  up to 120 days

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

  up to 104 weeks

Study Arms (2)

Narsoplimab

EXPERIMENTAL

Administration of Narsoplimab Vehicle: 5% dextrose in water

Biological: OMS721 (narsoplimab)

Vehicle

OTHER

Drug: Vehicle (5% dextrose in water)

Biological: OMS721 (narsoplimab)

Interventions

OMS721 (narsoplimab) BIOLOGICAL

Biological: narsoplimab

Also known as: narsoplimab

Narsoplimab; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (12)

Omeros Investigational Site

Denver, Colorado, 80230, United States

Location

Omeros Investigational Site

Augusta, Georgia, 30909, United States

Location

Omeros Investigational Site

Lawrenceville, Georgia, 30046, United States

Location

Omeros Investigational Site

Evergreen Park, Illinois, 60805, United States

Location

Omeros Investigational Site

Voorhees Township, New Jersey, 08043, United States

Location

Omeros Investigational Site

Flushing, New York, 11355, United States

Location

Omeros Investigational Site

San Antonio, Texas, 78215, United States

Location

Omeros Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Omeros Investigational Site

Chai Wan, Hong Kong

Location

Omeros Investigational Site

Hong Kong, Hong Kong

Location

Omeros Investigational Site

Kowloon, Hong Kong

Location

Omeros Investigational Site

Shatin, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 33163724 BACKGROUND

• Kidney Int Rep. 2020 Aug 13;5(11):2032-2041. doi: 10.1016/j.ekir.2020.08.003. eCollection 2020 Nov., PMID: 33163724

  BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA; Lupus Nephritis; Glomerulonephritis, Membranous

Interventions

narsoplimab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Omeros Clinical Trial Information
• Organization: Omeros

ctinfo@omeros.com

206-676-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort 2 and 3 participants were randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 studies were both open-label studies.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 15, 2016
• Study Start: March 10, 2016
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (4); US (8)