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

• Sponsor: Argos Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00960362
• Collaborator: (none)
• Enrollment: 13
• Locations: 6
• Arms: 7
• Duration (Months): 29
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 patients with systemic lupus erythematosus (SLE).

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Systemic Lupus Erythematosus (SLE)	Drug: AGS-009; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Frequency of adverse events [From dosing at visit 2 until end of safety visits at visit 8.]

Secondary Outcome Measures

1. Pharmacokinetic - AUC (area under the curve) [From dosing at visit 2 until end of safety visits at visit 8.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
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
5		Duncansville	Pennsylvania	United States	16635
6		Dallas	Texas	United States	75390

Sponsors and Collaborators

• Argos Therapeutics

Investigators

• Study Director: Fred Miesowicz, Ph.D., Argos Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Argos Therapeutics

Publications

None provided.

• Responsible Party: Argos Therapeutics
• ClinicalTrials.gov Identifier: NCT00960362
• Other Study ID Numbers: AGS-009-001
• First Posted: Aug 17, 2009
• Last Update Posted: Jan 30, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Inflammation

Study Results

No Results Posted as of Jan 30, 2012