Clinical trial NCT02682407: Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: IgAN
Lupus Nephritis
MN
C3 Glomerulopathy
Keywords: IgAN
Lupus Nephritis
MN
C3 Glomerulopathy
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy subjects with treatment related adverse events (AE).
timeFrame: up to 104 weeks
measure: Cohort 4: Proportion of IgAN patients of Asian descent with treatment related AEs.
timeFrame: 38 weeks
measure: Cohort 4: Change from baseline in serum and urine complement component levels.
timeFrame: 38 weeks
Secondary outcomes:
measure: Cohort 1-3: Change from baseline in serum narsoplimab concentrations.
timeFrame: up to 104 weeks
measure: Cohort 4: Change from baseline in serum narsoplimab concentrations.
timeFrame: 38 weeks
measure: Cohort1-3: Change from baseline in proteinuria.
timeFrame: up to 104 weeks
measure: Cohort1-3: Change from baseline in urine albumin/creatinine ratio.
timeFrame: up to 104 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Omeros Investigational Site
state: Colorado
city: Augusta
country: United States
facility: Omeros Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Omeros Investigational Site
state: Georgia
city: Evergreen Park
country: United States
facility: Omeros Investigational Site
state: Illinois
city: Voorhees
country: United States
facility: Omeros Investigational Site
state: New Jersey
city: Flushing
country: United States
facility: Omeros Investigational Site
state: New York
city: San Antonio
country: United States
facility: Omeros Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Omeros Investigational Site
state: Wisconsin
city: Chai Wan
country: Hong Kong
facility: Omeros Investigational Site
city: Hong Kong
country: Hong Kong
facility: Omeros Investigational Site
city: Kowloon
country: Hong Kong
facility: Omeros Investigational Site
city: Sha Tin
country: Hong Kong
facility: Omeros Investigational Site
Study officials:
References: