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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02682407
• Date of registration: 10/02/2016
• Prospective Registration: No
• Primary sponsor: Omeros Corporation
• Public title: Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
• Scientific 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
• Date of first enrolment: February 2016
• Target sample size: 54
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02682407
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Hong Kong, United States

Contacts

• Name: Omeros Clinical Trial Information

Key inclusion & exclusion 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:

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

C3 Glomerulopathy

MN

IgAN

Lupus Nephritis

Intervention(s)

Biological: OMS721 (narsoplimab)

Primary Outcome(s)

Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs. [Time Frame: 38 weeks]

Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE). [Time Frame: up to 104 weeks]

Cohort 4: Change from baseline in serum and urine complement component levels. [Time Frame: 38 weeks]

Secondary Outcome(s)

Cohort 4: Change from baseline in serum narsoplimab concentrations. [Time Frame: 38 weeks]

Cohort1-3: Change from baseline in proteinuria. [Time Frame: up to 104 weeks]

Cohort1-3: Change from baseline in urine albumin/creatinine ratio. [Time Frame: up to 104 weeks]

Cohort 1-3: Change from baseline in serum narsoplimab concentrations. [Time Frame: up to 104 weeks]

Secondary ID(s)

OMS721-GNP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors