Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

Inclusion Criteria

Subjects eligible for inclusion in this study must meet all of the following criteria:

• Subject must be able to understand and communicate with the investigator, comply with the requirements of the study. and must give written, signed and dated informed consent before any study assessment is performed
• Male and non-pregnant, non-lactating female patients ≥ 18 years of age
• Diagnosis of axSpA according to ASAS criteria
• Inflammatory back pain for at least 6 months
• Onset before 45 years of age
• For subjects with AS: Diagnosis of AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS
• For subjects with nr-axSpA:

X-ray of SIJ negative (centrally read) for AS by Modified NY criteria AND

• Sacroiliitis on MRI (centrally read) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features AND
• Objective signs of inflammation at screening, evident by either MRI with SIJ inflammation (centrally read) AND / OR hsCRP > ULN (as defined by the central lab)
• Active axial SpA assessed by BASDAI ≥4 cm (0-10 cm) at Baseline
• Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at Baseline
• Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at Baseline
• Subjects should have had inadequate response or failure to respond to at least 2 NSAIDs at an approved dose for a minimum of 4 weeks in total and a minimum of 2 weeks for each NSAID prior to randomization, or less than 4 weeks if therapy had to be withdrawn due to intolerance, toxicity or contraindications
• Subjects who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS or nr-axSpA therapy are required to be on a stable dose for at least 2 weeks before randomization
• Subjects who are intolerant or have been inadequate responders to a TNF inhibitor (not more than one) will be allowed to enter into the study (not more than 20% per group). They must have experienced an inadequate response to previous or current treatment at an approved dose for at least 3 months prior to randomization, or have been intolerant to at least one administration of an anti-TNF agent. These subjects will undergo an appropriate wash-out period prior to randomization, if required
• 4 weeks for Enbrel® (etanercept) - with a terminal half-life of 102 ± 30 hours
• 8 weeks for Remicade® (infliximab) - with a terminal half-life of 8.0-9.5 days
• 10 weeks for Humira® (adalimumab) - with a terminal half-life of 10-20 days (average 2 weeks)
• 10 weeks for Simponi® (golimumab) - with a terminal half-life of 11-14 days
• 10 weeks for Cimzia® (certolizumab) - with a terminal half-life of 14 days
• Subjects taking methotrexate (MTX) (≤ 25 mg/week ) or sulfasalazine (≤ 3 g/day) are allowed to continue their medication and must have taken it for at least 3 months and have to be on a stable dose for at least 4 weeks prior to randomization. Subjects on MTX must be on folic acid supplementation before randomization
• Subjects who are on a conventional DMARD other than MTX or sulfasalazine must discontinue the DMARD 4 weeks prior to randomization, except for leflunomide, which must be be discontinued 8 weeks prior to randomization, unless a cholestyramine washout has been performed
• Subjects taking systemic corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization

Exclusion Criteria

Subjects meeting any of the following criteria are not eligible for inclusion in this study

• Subjects with total ankylosis of the spine
• Chest x-ray or MRI with evidence of ongoing infectious or malignant process obtained within 3 months of screening and evaluated by a qualified physician
• Subjects taking moderate and high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
• Presence of significant medical problems which at investigator's discretion, will prevent the subject from particip