A randomized double-blind parallel-group multicenter study of secukinumab to compare 300 mg and 150 mg at Week 52 in patients with Ankylosing Spondylitis who are randomized to dose escalation after not achieving inactive disease during an initial 1

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ankylosing Spondylitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must be at least 18 years old
    2. Subjects must not be pregnant or breastfeeding
    3. Subjects who have diagnosis of moderate to severe AS with prior documented radiologic evidence
    4. Subjects who have active AS assessed by total BASDAI of = 4 (NRS of 0-10) at baseline
    5. Subjects who have spinal pain as measured by BASDAI question #2 of = 4 (NRS of 0-10) at baseline
    6. Subjects who have total back pain of = 4 on a NRS of 0-10 at baseline
    7. Subjects who have been on NSAIDs at the maximum tolerated dose for at least 4 weeks prior to their Baseline Visit
    8. Subjects who have 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. Subjects 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 an anti-TNFa agent
    10. Subjects who have previously been on a TNFa inhibitor will be allowed entry into study after appropriate wash-out period prior to two weeks before their Baseline Visit as per the protocol
    11. Subjects who are taking MTX (=25 mg/week), sulfasalazine (=3 g/day), or leflunomide (=20 mg/day) are allowed to continue their medication and must have taken it for at least 2 months and have to be on a stable dose for at least 4 weeks prior to baseline
    12. Subjects on MTX must be on a stable folic acid supplementation before their Baseline Visit.
    13. Subjects who are on a DMARD other than MTX, sulfasalazine or leflunomide must discontinue the DMARD 4 weeks prior to baseline
    14. Subjects who are taking systemic corticosteroids have to be on a stable dose of =10 mg/day prednisone or equivalent for at least 2 weeks before baseline

You may not be eligible for this study if the following are true:

    1. Subjects with total ankylosis of the spine
    2. Subjects who use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer
    3. Subjects with history of hypersensitivity to any of the study drugs or its excipients or to drugs of similarchemical classes
    4. Subjects with Chest x-ray, CT scan, or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process
    5. Subjects with p revious 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. Subjects who has who have taken more than one anti-TNFa agent
    7. Subjects with Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
    8. Subjects who have any therapy by intra-articular injections within 4 weeks before baseline
    9. Subjects with previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
    10. Subjects who are taking high potency opioid analgesics
    11. Subjects with active systemic infections during the last two weeks
    12. Subjects with active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy
    13. Subjects who have underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy
    14. Subjects who have significant medical problems or diseases
    15. Subjects with the history of clinically significant liver disease or liver injury as indicated by abnormal liver function tests
    16. Subjects with known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening
    17. Subjects with history of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
    18. Subjects who have inability or unwillingness to undergo repeated venipuncture
    19. Subjects who have inability or unwillingness to receive injections with the PFS
    20. Subjects who have any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol
    21. Subjects who have donation or loss of 400 mL or more of blood within 8 weeks before baseline
    22. Subjects with history or evidence of ongoing alcohol or drug abuse
    23. Subjects who are pregnant or breastfeeding
    24. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 16 weeks after stopping of study medication.

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