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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00818948 |
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 40 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 2 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.
Condition | Intervention | Phase |
---|---|---|
Lupus Nephritis |
Drug: AMG 811 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator
2 subjects of each cohort (cohort 1 to 5) will receive placebo
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Drug: AMG 811
Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). Doses planed for Cohorts 1, 2, and 3 are 6, 20 and 60 mg, respectively. 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 and 5 (6 AMG 811: 2 placebo). Doses planned for Cohorts 4 and 5 are 20 mg and 60 mg, respectively. Similar to Part A, subjects in Cohorts 4 and 5 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. |
AMG811
Six subjects in each cohort (cohort 1 to 5) will receive AMG 811
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Drug: AMG 811
Part A of the study will enroll SLE without GN (non-renal) subjects into 3 cohorts (6 AMG 811: 2 placebo). Doses planed for Cohorts 1, 2, and 3 are 6, 20 and 60 mg, respectively. 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 and 5 (6 AMG 811: 2 placebo). Doses planned for Cohorts 4 and 5 are 20 mg and 60 mg, respectively. Similar to Part A, subjects in Cohorts 4 and 5 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. |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Additional inclusion criteria for Part B:
- Active SLE with GN with no other apparent cause, defined by the following: Renal biopsy evidence (within 12 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; SLE subjects with GN who have had either a first episode of glomerulonephritis or reactivation of nephritis that has been previously controlled (with or without maintenance therapy) are eligible;
- Prednisone ≤ 20 mg/day (or equivalent) at the time of randomization.
Exclusion Criteria:
Additional exclusion criteria for Part B:
> 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).
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20070283 |
Study First Received: | December 18, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00818948 |
Health Authority: | United States: Food and Drug Administration |
Lupus Nephritis |
Glomerulonephritis Autoimmune Diseases Urologic Diseases Lupus Erythematosus, Systemic |
Nephritis Connective Tissue Diseases Kidney Diseases |
Immune System Diseases |