A Study of Ixekizumab in Patients with Psoriatic Arthritis

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients with Active Psoriatic Arthritis

• IRAS ID

  112393

• Contact name

  Hasan Tahir

• Sponsor organisation

  Eli Lilly & Company

• Eudract number

  2011-002326-49

• ISRCTN Number

  0000000

• Clinicaltrials.gov Identifier

  0000000

• Research summary

  Psoriatic Arthritis (PsA) is a form of Arthritis that people with Psoriasis may get. Some people have swelling or tenderness in their joints, and others can also get it in their spine. Interleukin-1? (IL-17) is a pro-inflammatory cytokine produced by a type of white blood cell called a T helper cell. IL-17 is involved in defense against certain types of infections, but uncontrolled IL-17 production may be involved in certain diseases including PsA and there are several pieces of evidence linking IL-17 to the pathology in PsA. Ixekizumab (LY2439821) is a humanized monocloncal antibody that is being developed for the treatment of patients with PsA. Ixekizumab has a high affinity for IL-17 and blocks the activity of IL-17 by preventing it from binding to the IL-17 receptor (IL-17R). The main purpose of this study is to examine the safety and efficacy of Ixekizumab. This study is also intended to evaluate the long-term safety and efficacy of Ixekizumab in PsA patients for up to 5 years. This study is a randomised, double blind, placebo controlled trial. In total, the study will include about 412 patients and will be conducted in several countries around the world. All patients will be allocated to one of four treatment groups consisting of the following: Three active treatment groups (Ixekizumab 80 milligrams every two weeks, Ixekizumab 80 milligrams every four weeks, Adalimumab (Humira) 40 milligrams every two weeks) and one placebo group. Treatment will be administered by injection (under the skin) at the study doctor??s hospital or by the patient at home. The study lasts for about 5 and a half years (Screening Period, 24 week double blind treatment period, 24 weeks extension period, 204 week long-term extension period and a 12 week post-treatment follow-up period).

• REC name

  Wales REC 3

• REC reference

  12/WA/0308

• Date of REC Opinion

  30 Nov 2012

• REC opinion

  Further Information Favourable Opinion