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

NCT00960362 | Completed Phase 1

• 1 other identifier: AGS-009-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 6

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).

Conditions

Inflammation; Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• Frequency of adverse events

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

Secondary Outcomes (1)

• Pharmacokinetic - AUC (area under the curve)

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

Study Arms (7)

A

PLACEBO COMPARATOR

Drug: placebo

B

EXPERIMENTAL

Intravenous cohort 1; 0.01 mg/kg

Drug: AGS-009

C

EXPERIMENTAL

Intravenous cohort 2; 0.1 mg/kg

Drug: AGS-009

D

EXPERIMENTAL

Intravenous cohort 3; 0.6 mg/kg

Drug: AGS-009

E

EXPERIMENTAL

Intravenous cohort 4; 3.0 mg/kg

Drug: AGS-009

F

EXPERIMENTAL

Intravenous cohort 5; 10 mg/kg

Drug: AGS-009

G

EXPERIMENTAL

Intravenous cohort 6; 30 mg/kg

Drug: AGS-009

Interventions

AGS-009 DRUG

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

B; C; D; E; F; G

placebo DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of SLE
• Disease duration longer or equal to 6 months
• Stable, mild to moderate active SLE
• Receiving stable maintenance therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Argos Therapeutics: lead

Study Sites (6)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Lake Success, New York, 11042, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Dallas, Texas, 75390, United States

Location

Related Links

• Argos Therapeutics

MeSH Terms

Conditions

Inflammation; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fred Miesowicz, Ph.D.

  Argos Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 30, 2012

Record last verified: 2012-01

Locations

US (6)