Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab
in adult patients of black race with systemic lupus erythematosus (SLE; lupus).
Study participants receive stable standard therapy for lupus in addition to receiving either
placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks.
The random assignment in this study is "2 to 1" which means that for every 3 participants, 2
will receive belimumab and 1 will receive placebo. Participants who successfully complete
the 52-week study may enter into a 6-month open-label extension. All participants in the
open-label extension receive belimumab plus standard therapy.
Key Inclusion Criteria:
- Black race.
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Active SLE disease.
- On stable SLE treatment regimen which may include corticosteroids (for example,
prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants
(for example, azathioprine, methotrexate, mycophenolate).
Key Exclusion Criteria:
- Pregnant or nursing.
- Have received treatment with any B cell targeted therapy (for example, rituximab or
belimumab) at any time.
- Have received treatment with an investigational biological agent in the past year.
- Have received intravenous (IV) cyclophosphamide within the past 90 days.
- Have severe active lupus kidney disease.
- Have severe 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.
- Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Have a history of severe allergic reaction to contrast agents or biological medicines