HGS1006-C1121 Phase 3 study of belimumab plus SoC in Lupus Nephritis
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis
IRAS ID
109846
Contact name
David D'Cruz
Sponsor organisation
Human Genome Sciences, Inc.
Eudract number
2011-004570-28
Clinicaltrials.gov Identifier
Research summary
This is a Phase 3, randomised, double-blind, placebo-controlled study to find out if belimumab is effective and safe in treating patients with active lupus nephritis who are receiving other standard lupus nephritis medicines. In the studies that have already been completed with belimumab, patients were not able to participate if they had severe active lupus nephritis. About 464 people from around the world who have active lupus nephritis will take part. Lupus nephritis is caused by an inflammation of the kidneys that can occur in people who have lupus (Systemic Lupus Erythematosus; SLE). Lupus is a disease in which the body??s immune system (the body system that fights infection) attacks the body's own cells and tissues, causing inflammation. It can damage organs in the body and it can affect almost any organ in the body. Participants will be placed into 1 of 2 groups at random. 1 group will receive belimumab and the other group with receive placebo. In addition to the belimumab or placebo, participants will also receive standard medicines for lupus nephritis. The main part of the study is 2 years (104 weeks) and during this time neither the participants nor the study doctors will know which study drug the participants are receiving (belimumab or placebo). Those who completed Part 1 (104 weeks), may continue in the study for an additional 6 months. During this time all participants will receive belimumab (there will be no placebo). In addition, participants who complete the main study will be invited to join the Pharmacogenetic Research Substudy. This study will aid the understanding of any differences in the way people respond to or handle belimumab. If written consent is given by the patient the sponsor may study these differences using participants' genes or genetic material taken from their blood samples.
REC name
London - Riverside Research Ethics Committee
REC reference
12/LO/1506
Date of REC Opinion
12 Oct 2012
REC opinion
Favourable Opinion