EMBODY 1

• Research type

  Research Study

• Full title

  A PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1)

• IRAS ID

  66047

• Sponsor organisation

  UCB Inc.

• Eudract number

  2010-018563-41

• ISRCTN Number

  N/A

• Research summary

  Systemic lupus erythematosus - often abbreviated to SLE or lupus - is a persistent or chronic systemic autoimmune disease (where the body's attacked by its own immune system). The disease can affect any part of the body, resulting in inflammation and tissue damage, but mostly affects the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. The disease is unpredictable and has periods of active disease (known as flares) and remission. There is currently no cure for lupus.UCB, Inc., are sponsoring a program of clinical trials using the new drug epratuzumab. The drug is believed to work, in part, by changing how B-cells (a type of white blood cell that produces antibodies, which detect and destroy foreign substances in the body) work and/or by reducing their number in the body, which may prevent the immune system from attacking healthy organs and thus reduce the level of inflammation. It is hoped that epratuzumab may provide a specific treatment of the signs and symptoms of SLE across many of the body systems affected by the disease. This study (SL0009) and an identical study (SL0010) will assess the safety and effectiveness of epratuzumab. The only difference between the studies will be in the participating sites but both will be run in the UK and worldwide. The study is a randomised, placebo-controlled trial, which will involve approximately 780 participants recruited from around 20 countries. Eligible patients will be randomly assigned (like drawing straws) to one of three treatment groups.?½ 600 milligrams (mg) of epratuzumab weekly for a total of 4 weeks in each 12-week treatment cycle OR ?½ 1200 mg of epratuzumab every other week for a total of 4 weeks in each 12-week treatment cycle (participants will receive 1200 mg of epratuzumab in the first and third week of every treatment cycle and placebo [a ??dummy?? substance that looks like epratuzumab, but has no active ingredient] in the second and fourth week) OR ?½ placebo weekly for a total of 4 weeks in each 12-week treatment cycle. Participants will be in the study for approximately one year. A variety of blood tests, study doctor assessments and participant completed questionnaires will be used.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0048

• Date of REC Opinion

  13 May 2011

• REC opinion

  Further Information Favourable Opinion