Status:
COMPLETED
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Argos Therapeutics
Conditions:
Inflammation
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- Diagnosis of SLE
- Disease duration longer or equal to 6 months
- Stable, mild to moderate active SLE
- Receiving stable maintenance therapy
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00960362
Start Date
July 1 2009
End Date
December 1 2011
Last Update
January 30 2012
Active Locations (6)
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1
Birmingham, Alabama, United States, 35294
2
Kansas City, Kansas, United States, 66160
3
Lake Success, New York, United States, 11042
4
Durham, North Carolina, United States, 27710