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Novartis ASLeap

Sponsor: Novartis


Patients/subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is preformed 2. Male or non-pregnant, non-lactating female patients at least 18 years of age 3. Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist’s report) fulfilling the Modified New York criteria for AS 4. Active AS assessed by total BASDAI = 4 (0-10) at baseline 5. Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline 6. Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline 7. Patients should have been on NSAIDs at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications 8. Patients who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before their Baseline Visit 9. Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or had been intolerant upon administration of that anti-TNFa agent Patients/subjects fulfilling any of the following criteria during the Screening Period or at the Baseline Visit are not eligible for inclusion in this study. 1. Patients with total ankylosis of the spine 2. Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer. 3. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. 4. Chest x-ray, CT scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within months prior to screening and evaluated by a qualified physician. 5. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17, IL-12/23, or the IL-17 receptor, or any other biologic immunomodulating agent, except those targeting TNFa 6. Patients who have taken more than one anti-TNFa agent 7. Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline 8. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline 9. Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis 10. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)

Indication: AS - Ankylosing Spondylitis
Protocol number: CAIN457FUS06
Phase: 4
Possible Stipend: $ 0