Back to results

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

Primary Purpose

Inflammation, Systemic Lupus Erythematosus (SLE)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AGS-009

placebo

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Intravenous cohort 1; 0.01 mg/kg

Intravenous cohort 2; 0.1 mg/kg

Intravenous cohort 3; 0.6 mg/kg

Intravenous cohort 4; 3.0 mg/kg

Intravenous cohort 5; 10 mg/kg

Intravenous cohort 6; 30 mg/kg

Outcomes

Primary Outcome Measures

Frequency of adverse events

Secondary Outcome Measures

Pharmacokinetic - AUC (area under the curve)

Full Information

NCT ID

NCT00960362

First Posted

August 14, 2009

Last Updated

January 26, 2012

Sponsor

Argos Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00960362

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Argos Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Systemic Lupus Erythematosus (SLE)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 1; 0.01 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 2; 0.1 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 3; 0.6 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 4; 3.0 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 5; 10 mg/kg

Arm Title

Arm Type

Experimental

Arm Description

Intravenous cohort 6; 30 mg/kg

Intervention Type

Drug

Intervention Name(s)

AGS-009

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of adverse events

Time Frame

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

Secondary Outcome Measure Information:

Title

Pharmacokinetic - AUC (area under the curve)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Miesowicz, Ph.D.

Organizational Affiliation

Argos Therapeutics

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.argostherapeutics.com

Description

Argos Therapeutics

Learn more about this trial

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

We'll reach out to this number within 24 hrs