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



Status:Recruiting
Conditions:Lupus, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/17/2018
Start Date:February 2016
End Date:December 2018
Contact:Soyoung Han
Email:shan@omeros.com
Phone:206-676-5000

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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 is to evaluate the safety and tolerability of OMS721 in subjects
with IgA Nephropathy (IgAN), Lupus Nephritis (LN), Membranous Nephropathy (MN), and C3
Glomerulopathy (C3G), including Dense Deposit Disease. The study will also evaluate
Pharmacokinetics (PK), Pharmacodynamics (PD), anti-drug antibody response (ADA), and
neutralizing antibodies (Nab).

This is a Phase 2, multicenter study of OMS721 in subjects with the following diseases: IgA
Nephropathy (IgAN), Lupus Nephritis, Membranous Nephropathy (MN), or C3 Glomerulopathy,
including Dense Deposit Disease. Three cohorts will be enrolled. Cohort 1 will be subjects
with corticosteroid dependent IgAN, LN, MN, or C3 Glomerulopathy. Cohort 1 subjects will all
receive OMS721 in an uncontrolled, open-label design. Cohort 2 and 3 will be subjects with
IgA nephropathy who are not receiving corticosteroids. These cohorts will be randomized to
receive either OMS721 treatment or D5W vehicle in a randomized double-blind design.
Approximately 44 subjects will be enrolled (16 in Cohort 1, 10 in Cohort 2, and 18 in Cohort
3).

Inclusion Criteria:

- Are at least 18 years of age

- Have a diagnosis of: IgAN, Lupus Nephritis, MN, or C3 Glomerulopathy including Dense
Deposit Disease

- Have 24-hour urine protein > 1000 mg/24 hours

- For subjects in Cohort 1, have been on ≥ 10 mg of prednisone or equivalent dose for at
least 12 weeks prior to Screening

- If on immunosuppressive treatment (e.g., cyclophosphamide, mycophenolate mofetil),
have been on a stable dose for at least 2 months prior to Screening Visit 1 with no
expected change in the dose for the study duration

- eGFR >= 30 mL/min/1.73 m2 calculated by the MDRD equation

- 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 < 9.0 g/dL

- Have a platelet count < 100,000/mm3

- Have an absolute neutrophil count < 500 cells/mm3

- Have an ALT or AST > 5.0 x the upper limit of normal

- 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

- Have a diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
infection, or positive serology at Screening

- Have any significant infection requiring antibiotic treatment at Screening

- 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

- Have an expectation of survival of less than 24 months

- For subjects in Cohort 2 and Cohort 3, have received corticosteroids within the 3
months prior to screening

- Subjects in Cohort 1 rolling into Cohort 3 must have IgAN and must have discontinued
corticosteroids prior to entry into Cohort 3, but the discontinuation may occur at any
time prior to Cohort 3 entry
We found this trial at
7
sites
Flushing, New York 11355
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Augusta, Georgia 30909
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Denver, Colorado 80230
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Evergreen Park, Illinois 60805
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Milwaukee, Wisconsin 53226
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San Antonio, Texas 78215
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Voorhees, New Jersey 08043
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