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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT00960362
First received: August 14, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Inflammation
Systemic Lupus Erythematosus (SLE)
Drug: AGS-009
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: From dosing at visit 2 until end of safety visits at visit 8. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic - AUC (area under the curve) [ Time Frame: From dosing at visit 2 until end of safety visits at visit 8. ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960362

Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, New York
Lake Success, New York, United States, 11042
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Argos Therapeutics
Investigators
Study Director: Fred Miesowicz, Ph.D. Argos Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00960362     History of Changes
Other Study ID Numbers: AGS-009-001
Study First Received: August 14, 2009
Last Updated: January 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Lupus Erythematosus, Systemic
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014