A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

A Multicenter, Randomized, Double-Blind and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Chinese Patients With Radiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).

Inclusion Criteria:

• Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
• Participants have a history of back pain ≥3 months with age at onset <45 years.
• Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
• Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
• Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

• Have total ankylosis of the spine.
• Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
• Have an ongoing or serious infection within the last 12 weeks.
• Have a compromised immune system.
• Have any other serious and/or uncontrolled diseases.
• Have either a current diagnosis or a recent history of malignant disease.
• Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
• Are pregnant or breastfeeding.