Systemic Lupus Erythematosus - Clinical Trial (07-02-81)
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects with Systemic Lupus Erythematosus.
Protocol ID
Protocol Description
Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disorder, which affects the skin, joints, kidneys and other organs. Certain naturally occurring proteins in the body are thought to be involved in auto-inflammatory diseases lupus. One such protein in the body is B7RP-1 and is thought to play a role in the cause of SLE. AMG 557 is an experimental monoclonal antibody that will potentially block the function of B7RP-1. The purpose of this research study is to evaluate the safety of a single dose of AMG 557 and to determine how the amount of this experimental drug in the body changes over time in adults with lupus. The information obtained from this study will be used for further developmentof AMG 557 for the treatment of lupus and possibly other inflammatory conditions.
Eligibility Criteria
Patients with systemic lupus erythematosis
Primary Investigator(s)
- Meggan Mackay, MD