A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)
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).
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:
Exclusion Criteria:
Pennsylvania, Wyoming 19610, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACI, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1419AHN, Argentina
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Ciudad Autonoma Buenos Aires, C1426AAL, Argentina
Hokkaido, 060-8604, Japan
Hokkaido, 060-8648, Japan
Gueishan Township,Taoyuan County, 333, Taiwan
Rajathevee, 10400, Thailand
Ratchatewi, 10400, Thailand