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

Phase 1

Completed

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

• Registration Number: NCT02443506
• Lead Sponsor: Amgen

Brief Summary

This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2007-04
• Study Completion: 2007-06
• Status Verified: 2015-04
• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-13
• Last Update Submitted: 2015-05-13
• Study First Posted: 2015-05-14
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Men and women, between the ages of 18 and 55
• Diagnosis of SLE
• Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria

• Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
• Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
• Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
• Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 623	AMG 623	Single dose of AMG 623 administered as subcutaneous and intravenous doses
Placebo	Placebo	Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	up to 70 days
Incidence of abnormal clinically significant vital signs	up to 70 days
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results	up to 70 days
Incidence of abnormal clinically significant ECG results	up to 70 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax	up to 70 days