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Completed

NCT Number: NCT00960362

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

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).

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Key information

Conditions

Inflammation Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases Systemic Lupus Erythematosus (SLE)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGS-009

Drug

Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)

Placebo

Drug

Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.

Primary outcomes

  1. Frequency of adverse events

    Time frame: From dosing at visit 2 until end of safety visits at visit 8.

Secondary outcomes

  1. Pharmacokinetic - AUC (area under the curve)

    Time frame: From dosing at visit 2 until end of safety visits at visit 8.

Sponsors and collaborators

Lead sponsor

Argos Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 17, 2009
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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