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

Sponsor:	Argos Therapeutics
Information provided by (Responsible Party):	Argos Therapeutics
ClinicalTrials.gov Identifier:	NCT00960362

Purpose

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).

Condition	Intervention	Phase
Inflammation Systemic Lupus Erythematosus (SLE)	Drug: AGS-009 Drug: placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus

Resource links provided by NLM:

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:

Frequency of adverse events [ Time Frame: From dosing at visit 2 until end of safety visits at visit 8. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic - AUC (area under the curve) [ Time Frame: From dosing at visit 2 until end of safety visits at visit 8. ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	July 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A	Drug: placebo Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
Experimental: B Intravenous cohort 1; 0.01 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Experimental: C Intravenous cohort 2; 0.1 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Experimental: D Intravenous cohort 3; 0.6 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Experimental: E Intravenous cohort 4; 3.0 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Experimental: F Intravenous cohort 5; 10 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)
Experimental: G Intravenous cohort 6; 30 mg/kg	Drug: AGS-009 Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960362

Locations

United States, Alabama

Birmingham, Alabama, United States, 35294
United States, Kansas

Kansas City, Kansas, United States, 66160
United States, New York

Lake Success, New York, United States, 11042
United States, North Carolina

Durham, North Carolina, United States, 27710
United States, Pennsylvania

Duncansville, Pennsylvania, United States, 16635
United States, Texas

Dallas, Texas, United States, 75390

Sponsors and Collaborators

Argos Therapeutics

Investigators

Study Director:

Fred Miesowicz, Ph.D.

Argos Therapeutics

More Information

Additional Information:

Argos Therapeutics This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Argos Therapeutics
ClinicalTrials.gov Identifier:	NCT00960362 History of Changes
Other Study ID Numbers:	AGS-009-001
Study First Received:	August 14, 2009
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Inflammation
Lupus Erythematosus, Systemic
Pathologic Processes

Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012