ILLUMINATE-X

• Research type

  Research Study

• Full title

  A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)

• IRAS ID

  95281

• Contact name

  Hasan Tahir

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-022101-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Systemic lupus erythematosus (SLE) is a chronic autoimmune disease (the immune system inappropriately targets host tissues and organ systems). It can result in arthritis, skin rashes, joint pain, tissue inflammation, blood abnormalities, renal inflammation, and central nervous system dysfunction. Conventional therapies such as Hydroxycholoroquine consist of antimalarials (drugs that are used to treat/prevent malaria) that are often combined with corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs). For more severe cases, immunosuppressive (reduces the activation of the immune system) or immunomodulatory (substance that has an effect on the immune system) agents may be used for the treatment of SLE. The drugs used to treat SLE are associated with additional risks and adverse effects. Therefore, treatments that allow for the reduction of the dose of corticosteroids necessary to control disease have a valuable place in the treatment of SLE. Eli Lilly and Company is sponsoring the development of an investigational drug called LY2127399. LY2127399 is an antibody that neutralises both soluble and membrane bound forms of B cell activating factor (BAFF). BAFF binds to B cells and may contribute to autoimmune diseases including SLE. This is a multinational, open label extension study that assesses the long term safety and efficacy or LY2127399 in patients who originally participated in the BCDT study. Patients will remain on the same dose as when they entered the previous study. Patients originally randomised (like flipping a coin) to placebo (inactive drug) during the original study will be randomised to active treatment in this study. Study participants will include men or women over 18 years with SLE. Approximately 1276 patients will be randomised into this study worldwide.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  12/EM/0444

• Date of REC Opinion

  19 Dec 2012

• REC opinion

  Further Information Favourable Opinion