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

Sponsor

Omeros Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02682407

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
IgAN Lupus Nephritis MN C3 Glomerulopathy	Biological: OMS721 (narsoplimab)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Cohort 2 and 3 subjects are randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 are non-randomized.Cohort 2 and 3 subjects are randomized in a 1:1 fashion during the first 12 weeks of treatment. Cohort 1 and 4 are non-randomized.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: OMS721 (narsoplimab)

Administration of OMS721 (narsoplimab)

Biological: OMS721 (narsoplimab)

Biological: OMS721 (narsoplimab)

Other Names:

narsoplimab

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

IgAN on kidney biopsy
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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omeros Investigational Site	Denver	Colorado	United States	80230
2	Omeros Investigational Site	Augusta	Georgia	United States	30909
3	Omeros Investigational Site	Lawrenceville	Georgia	United States	30046
4	Omeros Investigational Site	Evergreen Park	Illinois	United States	60805
5	Omeros Investigational Site	Voorhees	New Jersey	United States	08043
6	Omeros Investigational Site	Flushing	New York	United States	11355
7	Omeros Investigational Site	San Antonio	Texas	United States	78215
8	Omeros Investigational Site	Milwaukee	Wisconsin	United States	53226
9	Omeros Investigational Site	Chai Wan		Hong Kong
10	Omeros Investigational Site	Hong Kong		Hong Kong
11	Omeros Investigational Site	Kowloon		Hong Kong
12	Omeros Investigational Site	Sha Tin		Hong Kong