Overview

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

Status:
Completed

Trial end date:
2010-06-01

Target enrollment:
0

Participant gender:
All

Summary

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Amgen

Criteria

Inclusion Criteria:

- Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6
months before randomization; any concurrent SLE pharmacologic regimen (including
leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before
randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or
decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before
randomization

Exclusion Criteria:

- Subjects who, in the clinical judgment of the investigator, had severe disease;
subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ
systems at screening; signs or symptoms of a viral or bacterial infection within 30
days of study randomization, or recent history of repeated infections, evidence of
liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior
administration of another biologic that primarily targets the immune system within 1
year