Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: 150 mg open-label secukinumab; 150 mg double-blinded secukinumab; 300 mg double-blinded secukinumab
Intervention description: All patients in Treatment Period 1 received 150 mg s.c. injection open-label secukinumab.; Treatment Period 2 Patients who achieved responder status entered Treatment Period 2 and continued to receive 150 mg s.c. (1 s.c. injection of secukinumab 150 mg); Treatment Period 2 300 mg (2 s.c. injections of the 150 mg dose)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a randomized, double-blind, parallel-group, multicenter design which included an initial 16 week open-label period (Treatment Period 1) followed by a randomized, double-blind, parallel-group period (Treatment Period 2),
Masking: Double (Participant, Investigator)
Masking description: Patients and Investigators will be blinded to the secukinumab dose during Treatment Period 2.
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis; ASDAS inactive disease; secukinumab; ASDAS

Summary:

      This was a study estimating the clinical difference between 300 mg and 150 mg of secukinumab
      following dose escalation to 300 mg in patients with ankylosing spondylitis
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Understand and communicate with the investigator, comply with the requirements of the
             study and give a written, signed and dated informed consent

          2. Male or non-pregnant, non-lactating female patients at least 18 years of age

          3. Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented
             radiologic evidence fulfilling the Modified New York criteria for AS

          4. Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index
             (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 visual analog scale (VAS) ≥ 40 mm (0-100 mm) at
             baseline

          7. Patients should have been on non-steroidal anti-inflammatory drugs (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. Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2)
             inhibitors for at least 2 weeks before their Baseline Visit

          9. Patients who have been on a tumor necrosis factor alpha (TNFα) 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-TNFα agent

        Key Exclusion Criteria:

          1. 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, computerized tomography (CT) scan, or chest magnetic resonance imaging
             (MRI) with evidence of ongoing infectious or malignant process, obtained within 3
             months prior to screening and evaluated by a qualified physician.

          5. Previous exposure to secukinumab or any other biologic drug directly targeting
             Interleukin-17 (IL-17), Interleukin-12/23 (IL-12/23), or the IL-17 receptor, or any
             other biologic immunomodulating agent, except those targeting TNFα

          6. Patients who have taken more than one anti-TNFα 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. Previous treatment with any cell-depleting therapies

         10. Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone,
             morphine)

        Other protocol-defined inclusion/exclusion criteria may apply.