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

Last Updated: 2/19

Brief Summary

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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).

Interventions

Biological: OMS721
Other: Vehicle (D5W)

Phase

Status

Recruiting

Key Criteria

Conditions

IgAN
Lupus Nephritis
MN
C3G

Ages

18 and older

Sexes

All

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

Trial Locations

United States

Omeros Investigational Site

Denver, CO 80230

Omeros Investigational Site

Augusta, GA 30909

Omeros Investigational Site

Evergreen Park, IL 60805

Omeros Investigational Site

Voorhees, NJ 08043

Omeros Investigational Site

Flushing, NY 11355

Omeros Investigational Site

San Antonio, TX 78215

Omeros Investigational Site

Milwaukee, WI 53226

Choosing to participate in a study is an important personal decision

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided below.

Contact Information

Soyoung Han | 206-676-5000

shan@omeros.com

Sponsors and Collaborators

Omeros

www.omeros.com

View complete study information on ClinicalTrials.gov