I1F-MC-RHBE Ixekizumab in patients with active psoriatic arthritis

• Research type

  Research Study

• Full title

  Protocol I1F-MC-RHBE A Multicenter, Randomized, Double-Blind, Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients with Active Psoriatic Arthritis

• IRAS ID

  169177

• Contact name

  Hasan Tahir

• Contact email

  hasan.tahir@bartshealth.nhs.uk

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-002328-42

• Clinicaltrials.gov Identifier

  NCT02349295

• Duration of Study in the UK

  3 years, months, days

• Research summary

  Psoriatic Arthritis (PsA) is a form of Arthritis that people with Psoriasis (Ps) may get. Some people have swelling or tenderness in their joints, and others can also get it in their spine.
  Interleukin17 (IL17) is a proinflammatory cytokine produced by a type of white blood cell called a T helper cell. IL17 is involved in defense against certain types of infections, but uncontrolled IL17 production may be involved in certain diseases including PsA and there are several pieces of evidence linking IL17 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 IL17 and blocks the activity of IL17 by preventing it from binding to the IL17 receptor (IL17R).

  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 575 patients and will be conducted in several countries around the world. All patients will be allocated to one of three treatment groups consisting of the following: Two active treatment groups (Ixekizumab 80 milligrams every two weeks, Ixekizumab 80 milligrams every four 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, 132 week long term extension period and a 12 week post treatment
  follow up period).

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  15/LO/0282

• Date of REC Opinion

  13 Mar 2015

• REC opinion

  Further Information Favourable Opinion