Status:
COMPLETED
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
Lead Sponsor:
Amgen
Conditions:
Nephritis
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemi...
Detailed Description
Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). All subjects will receive a dose of AMG 811 or placebo every 4 weeks beginning with Day 1 (D1...
Eligibility Criteria
Inclusion
- Men and women, between the ages of 18 and 70 years of age;
- Body mass index from 18 to 40 kg/m2 \[Body Weight (kg)/Height2 (m2)\] at screening;
- Diagnosis of SLE at least 6 months before randomization, including a positive antinuclear antibodies (ANA) during screening; if screening ANA is negative, documented historical ANA with a titer of at least 1:80 will be acceptable;
- Any concurrent SLE pharmacologic regimen (including mycophenolate mofetil, azathioprine, leflunomide, methotrexate, and anti-malarials) must be stable for at least 30 days before randomization;
- Prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent will be allowed within 30 days before randomization;
- Additional inclusion criteria for Part B:
- \- Active SLE with GN with no other apparent cause, defined by the following: Renal biopsy evidence (within 18 months) of nephritis using the WHO or International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification of SLE with GN (Class III or IV); Urine protein/creatinine ratio (UP/Cr) \> 1 or 24 hour urine protein \> 1g after at least 12 weeks of treatment with mycophenolate mofetil (at least 1.5 grams/day) or azathioprine (at least 100 mg orally per day); Superimposed membranous changes are allowed for those with Class III or Class IV SLE with GN;
- \- Prednisone ≤ 20 mg/day (or equivalent) at the time of randomization.
Exclusion
- Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator's discretion;
- Creatinine clearance within the screening period of less than 50 mL/min as calculated by the Cockcroft-Gault method
- Signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization, or recent history of repeated infections;
- Underlying condition other than SLE or being on allowed immunosuppressants that predisposes one to infections
- Prior use of the following agents:
- Administration of an investigational biologic agent that primarily targets the immune system
- Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization;
- Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 12 months (Part A) or 3 months (Part B) of randomization;
- History of ethanol or drug abuse within the last one year prior to randomization;
- Additional exclusion criteria for Part B:
- Rapidly progressive GN (defined as a doubling of serum creatinine within the past 3 months);
- Evidence of significant chronicity, defined as:
- \> 50% glomeruli with sclerosis or \> 50% interstitial fibrosis on renal biopsy; or International Society of Nephrology (ISN)/Renal Pathology Society (RPS) 2003 Class III (C), IV-S (C) or IV-G (C).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00818948
Start Date
March 1 2009
End Date
August 1 2014
Last Update
September 15 2014
Active Locations (12)
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1
Research Site
Phoenix, Arizona, United States, 85013
2
Research Site
Danbury, Connecticut, United States, 06810
3
Research Site
Kansas City, Kansas, United States, 66160
4
Research Site
Manhasset, New York, United States, 11030