RSH_I1F-MC-RHBV

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 bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis

Inclusion Criteria:

Are ambulatory.
Diagnosis of radiographic axial spondyloarthritis (rad-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.
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
If taking NSAIDS be on a 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 total ankylosis of the spine.
Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
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 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.
Phase III
NCT02696785
All Other
Rheumatology
Kalpita Hatti, M.D.
Eli Lilly and Company
Cheryl Albin
  • Kadlec Research