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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00960362

Enrollment

Registered

2009-08-17

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2012-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Systemic Lupus Erythematosus (SLE)

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).

Interventions

DRUGAGS-009

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026