Belimumab vs placebo, plus standard therapy in paediatric SLE

• Research type

  Research Study

• Full title

  A Multi-centre, Randomised, Parallel Group, Placebo-controlled Double-blind Trial to Evaluate the Safety, Efficacy and Phamacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Paediatric Patients with Systemic Lupus Erythematosus (SLE).

• IRAS ID

  104793

• Contact name

  Eileen Baildam

• Eudract number

  2011-000368-88

• Duration of Study in the UK

  28 years, 9 months, 11 days

• Research summary

  This study is to test the safety and efficacy of Belimumab in children with Systemic Lupus Erythematosus (SLE)
  In SLE, antibodies created by the patient’s immune system attack their own body tissues. This causes inflammation in many different parts of the body resulting in symptoms such as skin rashes, extreme tiredness, and joint problems. It may also affect the kidneys, heart, lungs and nervous system and can cause serious damage if not treated.
  Belimumab works by blocking a protein in the blood which can make SLE active. It has been approved for use in some adults with SLE but not in children.
  This study, sponsored by GlaxoSmithKline, will enrol 100 participants globally.
  Eligible participants will be aged 5-17 years, have active SLE disease and be on stable SLE treatment.
  Cohort 1 - 12 participants aged 12-17 years.
  Cohort 2 - 12 participants aged 5-11 years.
  Cohort 3 - 76 participants aged 5-17 years.
  Enrolment into cohort 2, and 12-17 years old in cohort 3 will only begin after participants in cohort 1 have completed 8 weeks of treatment and the results have been analysed.
  Enrolment of 5-11 year olds into cohort 3 will only begin after participants in cohort 2 have completed 8 weeks of treatment and the results have been analysed.
  Participants will receive either Belimumab or placebo (salt water solution) in addition to their standard treatment. Participants who complete 48 weeks of treatment may progress to a phase where everyone will receive Belimumab. Those withdrawing from treatment earlier will be followed up for safety. This part of the study may last up to 10 years.
  Study visits will take place every 4 weeks. At each visit, study treatment will be given through a drip into a vein. Various disease activity questionnaires and blood tests will also be performed.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0367

• Date of REC Opinion

  13 Jun 2012

• REC opinion

  Further Information Favourable Opinion