Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
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ClinicalTrials.gov Identifier: NCT00818948 |
Recruitment Status :
Completed
First Posted : January 8, 2009
Last Update Posted : September 15, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nephritis Systemic Lupus Erythematosus | Drug: AMG 811 | Phase 1 |
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) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication.
Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5, and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5, and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
2 subjects of each cohort (cohort 1 to 6) will receive placebo
|
Drug: AMG 811
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) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period. |
AMG811
Six subjects in each cohort (cohort 1 to 6) will receive AMG 811
|
Drug: AMG 811
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) for a total of 3 injections. Subjects will be followed through to study day 197, 5 months from the last dose of study medication. Part B of the study will enroll SLE subjects with GN into Cohorts 4, 5 and 6 (6 AMG 811: 2 placebo). Similar to Part A, subjects in Cohorts 4, 5 and 6 will be dosed every 4 weeks with AMG 811 or placebo for a total of 3 injections followed by a 5 month follow-up period. For Cohort 6, subjects will be followed by a 6 month follow-up period. |
- Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies [ Time Frame: 197 days ]
- Serum and urine PK parameters of AMG 811 [ Time Frame: 197 days ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818948
United States, Arizona | |
Research Site | |
Phoenix, Arizona, United States, 85013 | |
United States, Connecticut | |
Research Site | |
Danbury, Connecticut, United States, 06810 | |
United States, Kansas | |
Research Site | |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
Research Site | |
Manhasset, New York, United States, 11030 | |
Research Site | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
Research Site | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
Research Site | |
Amarillo, Texas, United States, 79106 | |
Research Site | |
Dallas, Texas, United States, 75231 | |
France | |
Research Site | |
Paris Cedex 13, France, 75651 | |
Hong Kong | |
Research Site | |
Hong Kong, Hong Kong | |
Malaysia | |
Research Site | |
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603 | |
Mexico | |
Research Site | |
Mexico, Distrito Federal, Mexico, 14000 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00818948 |
Other Study ID Numbers: |
20070283 |
First Posted: | January 8, 2009 Key Record Dates |
Last Update Posted: | September 15, 2014 |
Last Verified: | August 2014 |
Lupus Nephritis |
Nephritis Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Kidney Diseases Urologic Diseases |