A study of atacicept in patients with Lupus Nephritis

• Research type

  Research Study

• Full title

  A Phase Ib, Multicentre, Open Label, Dose-Escalating, Repeat-Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept when Administered to Subjects with Lupus Nephritis on a Stable Regimen of Mycophenolate Mofetil (MMF) With or Without Corticosteroids

• IRAS ID

  71085

• Sponsor organisation

  Clinical Trial Management Early Development

• Eudract number

  2010-022154-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Systemic lupus erythematosus (SLE or lupus) is an autoimmune disease characterised by inflammation of tissues in the body. The body's immune system normally attacks foreign matter, such as bacteria and viruses. In autoimmune disease, however, the immune system abnormally attacks the body's own tissues. The immune system is composed of specialised cells as well as proteins that they produce, including antibodies. In autoimmune diseases such as SLE, ??autoantibodies? are produced which attack one??s own tissues.Sometimes SLE results in inflammation of the kidney; this is known as lupus nephritis (LN). Current treatments for LN include corticosteroids and other drugs which decrease the immune system activity. Unfortunately the drugs may cause significant side effects, such as increasing one??s risk for infection. It is thus challenging to treat LN, and there is a great unmet need for new treatments.Atacicept is a fusion protein designed to decrease the production of autoantibodies. It binds to 2 growth factors that stimulate specialised immune cells, called B cells and plasma cells, which produce antibodies and autoantibodies. By reducing levels of autoantibodies, atacicept may decrease tissue inflammation and damage from SLE. This includes the kidney for patients with LN. Atacicept has been evaluated in patients with diseases such as rheumatoid arthritis, multiple sclerosis, SLE or LN. In a previous trial in which LN patients were treated with atacicept or a placebo (inactive substance), there was an increased risk of infection in the atacicept-treated patients compared to the placebo-treated subjects. All of the patients were started on mycophenolate mofetil (MMF) and high-dose corticosteroids 2 weeks before the atacicept was started. The current trial is thus aimed at evaluating the effects of atacicept in patients with LN who have not recently been started on MMF and corticosteroids, but rather are now on stable doses of these medications. The focus of the study is on the safety of atacicept in these patients, as well as its biologic effects (in particular, the effect on levels of antibodies) and blood concentrations in these patients.This is a dose escalating study where sequential cohorts of patients will be treated with 25mg, 75mg or 150mg atacicept weekly for 12 weeks. The study is sponsored by Merck Serono S.A-Geneva (outside the U.S) and EMD Serono Inc (inside the U.S.) and will take place at approximately 15-18 clinical centres in Western Europe and North America. It is planned that 25 to 35 patients will be enrolled in this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/0161

• Date of REC Opinion

  26 May 2011

• REC opinion

  Further Information Favourable Opinion