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 (I1F-MC-RHBX)

INTERVENTION: investigational material(s) Generic name etc : Ixekizumab (LY2439821) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52. Generic name etc : Ixekizumab (LY2439821) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Double Blind Period: Placebo given SC Q2W to week 52. CONDITION: Axial spondyloarthritis 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 <45 years. ‐Have active nr‐axSpA defined as >=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 necr