An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

Completed · Phase 1 · Has a placebo group

Conditions studied: Inflammation, Systemic Lupus Erythematosus (SLE)

In brief

This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).

Key facts

Study ID

NCT00960362

Run by

Argos Therapeutics

People needed

13

Starts

2009-07-01

Expected to finish

2011-12-01

Last updated by the study team

2012-01-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE
• Disease duration longer or equal to 6 months
• Stable, mild to moderate active SLE
• Receiving stable maintenance therapy

You may not qualify if…

• Significant lupus nephritis
• Active central nervous system (CNS) disease
• Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
• Active vasculitis requiring treatment
• Body weight over 120 kg
• History of cancer
• Infections
• viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
• tuberculosis (TB)
• Severe systemic microbial infections within the past 12 months prior to dosing
• Immunosuppressive and immune modulating therapy

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Kansas City, Kansas, United States
• Study site — Lake Success, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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