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

Study Overview
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Brief Summary
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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).

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

Conditions
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Inflammation, Systemic Lupus Erythematosus (SLE)

Intervention / Treatment
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* Drug: AGS-009
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: placebo<br>* Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.<br>|
| Experimental: B<br>Intravenous cohort 1; 0.01 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|
| Experimental: C<br>Intravenous cohort 2; 0.1 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|
| Experimental: D<br>Intravenous cohort 3; 0.6 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|
| Experimental: E<br>Intravenous cohort 4; 3.0 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|
| Experimental: F<br>Intravenous cohort 5; 10 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|
| Experimental: G<br>Intravenous cohort 6; 30 mg/kg | Drug: AGS-009<br>* Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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