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

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: AMG 623

• Registration Number: NCT02411136
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-08
• Study Completion: 2007-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-07
• Last Update Submitted: 2015-04-07
• Study First Posted: 2015-04-08
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
AMG 623	AMG 623	Multiple doses of AMG 623 administered as subcutaneous and intravenous doses

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax	up to 31 weeks