Efficacy and Safety of LY2127399 in Patient with SLE
Research type
Research Study
Full title
A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)
IRAS ID
64331
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2010-022100-42
Clinicaltrials.gov Identifier
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, randomised, double-blind, placebo-controlled trial, meaning that patients will be randomly assigned (like the toss of a coin) to LY2127399 or placebo (inactive drug). Study participants will include men or women over 18 years with SLE. Approximately 1140 patients will be randomised into this study worldwide.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
11/EM/0064
Date of REC Opinion
28 Apr 2011
REC opinion
Further Information Favourable Opinion