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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00774943 |
This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: AMG 557 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus |
Estimated Enrollment: | 32 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AMG 557: Active Comparator |
Drug: AMG 557
A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.
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Placebo: Placebo Comparator |
Drug: AMG 557
A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The glomerular fitration rate < 50 mL/min using the Cockroft and Gault equation;
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20060169 |
Study First Received: | October 16, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00774943 |
Health Authority: | Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Systemic lupus erythematosus ICOSL B7RP-1 Costimulation |
Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Immune System Diseases |