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Clinical Trials

Systemic Lupus Erythematosus Study

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects with Systemic Lupus Erythematosus

Protocol ID

07-02-190

Protocol Description

Certain naturally occurring proteins in the body are thought to be involved in auto inflammatory diseases like systemic lupus erythematosus (SLE). One such protein in the body is interferon gamma (IFN-γ). AMG 811 is an experimental drug designed to inhibit the function of IFN-γ. The purpose of this study is to evaluate the safety of single doses of AMG 811 and to determine how the amount of this study drug in the body changes over time in adults with lupus. It is the first time that AMG 811 will be given to humans. The information obtained from this study will be used to evaluate AMG 811 for use in lupus or possibly other inflammatory conditions.

Eligibility Criteria

Patients with systemic lupus erythematosus

Primary Investigator(s)

  • Cynthia Aranow, MD

Contact Information

Sanita Kandasami
(516) 562-240
skandasami@nshs.edu

Last Update

April 2, 2010
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