SHS_280162 MEAP CELI 16059

SHS 280162 MEAP CELI 16059-A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Inclusion Criteria:

Are ambulatory.
Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 ASAS classification criteria.
Have a history of back pain ≥3 months with age at onset <45 years.
Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a NRS at screening and baseline.
Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated CRP.
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

Exclusion Criteria:

Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
Have 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 or evidence of active tuberculosis.
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.
Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
Phase III
All Other
Philip Mease, M.D.
Eli Lilly and Company
Allison Everett
  • Swedish Medical Center