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

Phase 1

Completed

• Conditions: Inflammation; Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: placebo; Drug: AGS-009

• Registration Number: NCT00960362
• Lead Sponsor: Argos Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	placebo	-
B	AGS-009	Intravenous cohort 1; 0.01 mg/kg
C	AGS-009	Intravenous cohort 2; 0.1 mg/kg
D	AGS-009	Intravenous cohort 3; 0.6 mg/kg
E	AGS-009	Intravenous cohort 4; 3.0 mg/kg
F	AGS-009	Intravenous cohort 5; 10 mg/kg
G	AGS-009	Intravenous cohort 6; 30 mg/kg

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events	From dosing at visit 2 until end of safety visits at visit 8.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic - AUC (area under the curve)	From dosing at visit 2 until end of safety visits at visit 8.