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

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled,
52-week study to evaluate the efficacy, safety and tolerability of belimumab administered
subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus
Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of
about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects
completing the 52-week double-blind period can enter a 6-month open-label extension in which
all subjects receive belimumab 200 mg SC weekly.

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.