I1F-MC-RHAO: Ixekizumab (LY2439821) in Ankylosing Spondylitis Patients
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis
IRAS ID
124462
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2011-002325-22
Research summary
Ankylosing Spondylitis (AS) is a form of arthritis that primarily affects the spine. It causes inflammation of the spinal joints (vertebrae) that can lead to severe, chronic pain and discomfort.
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 AS and there are several pieces of evidence linking IL17 to the pathology in AS.
Ixekizumab (LY2439821) is a humanized monocloncal antibody that is being developed for the treatment of patients with AS. Ixekizumab has a high affinity for IL17 and blocks the activity of IL17 by preventing it from binding to the IL17 receptor (IL17R).
Study I1F-MC-RHAO is a Phase 3, multicenter, randomized, active and placebo-controlled, parallel-group, outpatient study to evaluate the efficacy and safety of Ixekizumab versus placebo at 16 weeks in patients with active AS who are biologic naive or had an inadequate response to not more than 1 TNFα inhibitor. Patients will be randomized to subcutaneous placebo, Adalimumab (Humira®; AbbVie), or 1 of 2 dose regimens of Ixekizumab (80 mg every 2 weeks [Q2W] or every 4 weeks [Q4W], each with a starting dose of 160 mg). This study will also evaluate long-term efficacy and safety of Ixekizumab during an Extended Treatment Period (36 weeks) and a Long-Term Extension Period (2 years). All patients entering into the Extended Treatment Period from placebo or adalimumab arms will be rerandomized to either of the ixekizumab treatment arms for the remainder of the study. The study duration is a total of approximately 3 years. Approximately 680 patients will take part in this study worldwide.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0573
Date of REC Opinion
26 Sep 2013
REC opinion
Further Information Favourable Opinion