A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

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

Details

• Lead Sponsor: Human Genome Sciences Inc., a GSK Company
• Collaborator: GlaxoSmithKline
• Treatments: Belimumab

Criteria

Inclusion Criteria:

1. At least 18 years of age.

2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.

3. Active SLE disease.

4. Autoantibody-positive.

5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

1. Pregnant or nursing.

2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).

3. Have received treatment an investigational biological agent in the past year.

4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.

5. Have severe active lupus kidney disease.

6. Have severe active central nervous system (CNS) lupus.

7. Have required management of acute or chronic infections within the past 60 days.

8. Have current drug or alcohol abuse or dependence.

9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.