Systemic Lupus Erythematosus - Clinical Trial (07-02-283)
A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE)
Protocol ID
Protocol Description
Systemic lupus erythematosus (SLE) is a chronic (long term) autoimmune disease of unknown cause. SLE can affect different people in different ways, but it oftne involves chronic inflammation and organs can be damaged. The ways in which this happens are becoming clearer to doctors, and research into SLE suggests that the expermintal drug, atacicept, might play a role in controlling the symptoms and signs of the disease.
The purpose of this research study is to evaluate how well atacicept works, how safe it is, and to identify the best dose of atacicept for SLE. In addition, the study will measure the effects of atacicept on some substances in the blood which measure the "activity" or severity of SLE. This study will also look at possible effects of atacicept on the progression of SLE.
Eligibility Criteria
Patients with systemic lupus erythematosus
Primary Investigator(s)
- Cynthia Aranow, MD