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