Ixekizumab in Ankylosing Spondylitis
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis
IRAS ID
196490
Contact name
Karl Gaffney
Contact email
Sponsor organisation
Eli Lilly & Company Limited
Eudract number
2015-003937-84
Duration of Study in the UK
2 years, 2 months, 9 days
Research summary
Axial spondyloarthritis (axSpA) is a long-term inflammatory disease mainly affecting the sacroiliac joints and spine. AxSpA can be divided into two sub-groups; rad-axSpA and nonrad-axSpA. Rad-axSpA refers to damage to the sacroiliac joints that can be defined radiographically whereas nonrad-axSpA means clear structural damage cannot be seen using radiographic imaging.
AxSpA affects up to 1.1% of the Caucasian adult population. The exact cause is unknown but genetic factors may contribute to the risk of contracting the disease. There is a strong association with the HLA-B27 gene and about 80% to 95% of patients with rad-axSpA are HLA-B27-positive.
Current standard of care for rad-axSpA includes regular exercise, physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and tumor necrosis factor (TNF) alpha inhibitors. NSAIDs are the most common drug treatment for axSpA but are not effective or well tolerated in all patients. TNF inhibitors are effective in treating some of the signs and symptoms and may improve the quality of life of patients and are usually prescribed when NSAID treatment has failed or cannot be tolerated.
IL17A has been identified as a protein involved in inflammation and the pathway leading to axSpA. Ixekizumab is a humanized monoclonal antibody which is designed to suppress IL17A and therefore reduce inflammation and may be an alternative treatment to TNF inhibitor therapy in patients with axSpA.
The purpose of this study is to compare the effectiveness and safety of two doses of ixekizumab in patients with rad-axSpA over 16 weeks of treatment. The study will also evaluate the long-term effectiveness and safety of ixekizumab for 1 year (52 weeks).
Eligible patients must be aged 18 years with a diagnosis of rad-axSpA and have had prior treatment with TNF inhibitors
Study assessments will include: Physical examinations, X-rays of the chest, pelvis and spine, blood & urine tests and questionnaires.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0037
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion