An Investigation of AGS-009 in Patients With Systemic Lup... | NCT00960362

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

NCT00960362

Sponsor

Argos Therapeutics

Status

Completed

Last Update Posted

Jan 30, 2012Estimated

Enrollment

13Actual

Phase

Phase 1

Conditions

Inflammation
Systemic Lupus Erythematosus (SLE)

Interventions

AGS-009
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 14, 2009

First Submission Date that Met QC Criteria

Aug 14, 2009

First Posted Date

Aug 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2012

Last Update Posted Date

Jan 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fred Miesowicz, Ph.D.	Argos Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

Label	URL
Argos Therapeutics	View source

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D008180	Lupus Erythematosus, Systemic

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided