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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

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