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

Inflammation Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960362
• Other study ID #: AGS-009-001
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2009
• Last updated: January 26, 2012
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Argos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus (SLE)

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Argos Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events		From dosing at visit 2 until end of safety visits at visit 8.	Yes
Secondary	Pharmacokinetic - AUC (area under the curve)		From dosing at visit 2 until end of safety visits at visit 8.	No

External Links

•   Argos Therapeutics