Axial spondyloarthritis
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Are ambulatory. -Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 ASAS classification criteria. -Have a history of back pain >= months with age at onset =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.
Exclusion criteria
Exclusion criteria:
Outcome results
None listed