HGS1006-C1115 Phase 3 Belimumab Administered SC to patients with SLE

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  95097

• Contact name

  David D'Cruz

• Sponsor organisation

  Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

• Eudract number

  2011-003814-18

• Clinicaltrials.gov Identifier

  NCT01484496

• Research summary

  This is a research study on a study 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 administered as an injection under the skin (subcutaneously; SC) in treating patients with active lupus who are receiving other lupus medicines. Currently belimumab is only approved for use when administered into a vein. Participants will be placed into 1 of 2 groups. 1 group will self-administer a weekly injection under the skin (SC) of belimumab and the other group will self-administer a weekly injection under the skin (SC) of placebo (injection containing 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 first dose of study agent will be administered on Day 0 and then weekly (ie, every 7 days ñ 1 day) through 51 weeks, with a final evaluation at Week 52 (1 week after the last dose). Participants who successfully complete the initial 52 week study may enter into a 6-month extension phase, where everyone will receive belimumab. 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 - Central Research Ethics Committee

• REC reference

  12/LO/0512

• Date of REC Opinion

  5 Apr 2012

• REC opinion

  Favourable Opinion