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

January 26, 2012 updated by: Argos Therapeutics

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • New York
      • Lake Success, New York, United States, 11042
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • Texas
      • Dallas, Texas, United States, 75390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argos Therapeutics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (ESTIMATE)

August 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGS-009-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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