A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: AMG 623
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 18 and 65 years old Diagnosis of SLE Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization SLE disease duration of at least 1 year, as diagnosed by a physician Exclusion Criteria: Current renal disease Signs or symptoms of viral or bacterial infection within 30 days of enrollment Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 623<br>Multiple doses of AMG 623 administered as subcutaneous and intravenous doses | Drug: AMG 623<br>* Multiple doses of AMG 623 administered as subcutaneous and intravenous doses<br>|
| Placebo Comparator: Placebo<br>Multiple doses of AMG 623 administered as subcutaneous and intravenous doses | Drug: Placebo<br>* Multiple doses of AMG 623 administered as subcutaneous and intravenous doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events |  | up to 31 weeks | 
| Incidence of abnormal clinically significant vital signs |  | up to 31 weeks | 
| Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results |  | up to 31 weeks | 
| Incidence of abnormal clinically significant ECG results |  | up to 31 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax |  | up to 31 weeks |