An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00960362
Last Updated: 2012-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2009-07-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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A
placebo
Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
B
Intravenous cohort 1; 0.01 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
C
Intravenous cohort 2; 0.1 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
D
Intravenous cohort 3; 0.6 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
E
Intravenous cohort 4; 3.0 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
F
Intravenous cohort 5; 10 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
G
Intravenous cohort 6; 30 mg/kg
AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Interventions
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AGS-009
Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
placebo
Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
Eligibility Criteria
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Inclusion Criteria
* Disease duration longer or equal to 6 months
* Stable, mild to moderate active SLE
* Receiving stable maintenance therapy
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Argos Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Fred Miesowicz, Ph.D.
Role: STUDY_DIRECTOR
Argos Therapeutics
Locations
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Birmingham, Alabama, United States
Kansas City, Kansas, United States
Lake Success, New York, United States
Durham, North Carolina, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
Countries
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Related Links
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Argos Therapeutics
Other Identifiers
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AGS-009-001
Identifier Type: -
Identifier Source: org_study_id
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