HGS1006-C1112 Phase 3/4 Study of Belimumab in Black Race SLE Patients
Research type
Research Study
Full title
A Phase 3/4, Multi-Centre, 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)
IRAS ID
119192
Contact name
David D'Cruz
Contact email
david.d'cruz@kcl.ac.uk
Sponsor organisation
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)
Eudract number
2011-005672-42
Clinicaltrials.gov Identifier
Research summary
This is a research study on a drug called belimumab, which is being tested as a treatment for systemic lupus erythematosus (SLE). Lupus is a disease in which the immune system (the system that fights infection) attacks cells and tissues, causing inflammation. It can affect almost any organ in the body. The purpose of this study is to find out if belimumab is safe and effective when given to adults of black race with SLE. Approximately 816 people of self-identified black race with SLE will take part around the world.
Participants will be placed into 1 of 2 groups. 1 group will receive belimumab and the other group will receive placebo (looks like the study drug but contains no active medicine). The random assignment in this study is “2 to 1” meaning that for every 3 participants, 2 participants will receive belimumab and 1 participant will receive placebo. Neither the patient nor the study doctor will know if belimumab or placebo is being received.
The study drug will be administered on Days 0, 14, 28, and then every 28 days through 48 weeks, with a final evaluation at Week 52 (4 weeks after the last dose). Study agent will be administered intravenously (IV; injected into a vein) over 1 hour. All subjects will continue the stable standard therapy they were receiving during the screening period.
Participants who successfully complete the initial 52 week study may enter into a 6-month open-label extension, where everyone will receive belimumab every 28 days.
In addition, participants will be invited to join the Pharmacogenetic Research Sub-study. 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
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0195
Date of REC Opinion
11 Jun 2013
REC opinion
Further Information Favourable Opinion