Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.
• Collaborator: GlaxoSmithKline
• Treatments: Belimumab

Criteria

Inclusion Criteria:

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria

• Active SLE disease

• On stable SLE treatment regimen

Exclusion Criteria:

• Pregnant or nursing

• Have received treatment with an B cell targeted therapy

• Have received treatment with a biologic investigational agent in the past year

• Have received intravenous (IV) cyclophosphamide within 180 days of Day 0

• Have severe lupus kidney disease

• Have active central nervous system (CNS) lupus

• Have required management of acute or chronic infections with the past 60 days

• Have current drug or alcohol abuse or dependence or within the past year

• Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C

• Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention