A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Key Inclusion Criteria:

• Clinical diagnosis of SLE by ACR criteria.

• Active SLE disease.

• Autoantibody-positive.

• On stable SLE treatment regimen.

Key Exclusion Criteria:

• Pregnant or nursing

• Have received treatment with any B cell targeted therapy.

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

• Have received 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 within the past 60 days.

• Have current drug or alcohol abuse or dependence.

• Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.