Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

Exclusion Criteria

• •Complete ankylosis (fusion) of the spine; Subject has a positive test for tuberculosis
• •Subject has a planned surgical intervention between baeline and week 16
• •Subject has an active infection or history of infections as follows (any active infection for which systemic anti-infectives were used within 28 day prior to the first MP dose
• •A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose
• •Recurrent or chronic infections or other active infection that, in the opinion ofthe investigator might cause this study to be detrimental to the subject)
• •Subject has active Crohn's disease or a history of Crohn's disease
• •Subject has active ulcerative colitis requiring daily use of immunosuppressive therapy
• •Subject has had active fibromyalgia within the past 12 months
• •Subject has a prior history of greater than 1 anti-TNF therapy for ankylosing spondylitis
• •Subject has used commercially available or investigational biologic therapies for ankylosing spondylitis as follows
• •* Anti-tumor necrosis factor (TNF) therapy as follows: within 1 month prior to IMP initiation for etanercept and within 2 months prior to IMP initiation for other anti-TNF agents.
• •* Other experimental or commercially available biologic therapies for ankylosing spondylitis within 3 months prior to IMP initiation
• •* Anti-IL17 biologics (eg, brodalumab, secukinumab, ixekizumab) or anti-IL12/IL23 biologic therapy (eg, ustekinumab, briakinumab) at any time
• •* Rituximab at any time