Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
Study estimating the clinical difference between 300 mg and 150 mg of secukinumab following dose escalation to 300 mg in patients with ankylosing spondylitis
- Ankylosing Spondylitis
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Understand and communicate with the investigator, comply with the requirements of the study and give a written, signed and dated informed consent
- Male or non-pregnant, non-lactating female patients at least 18 years of age
- Diagnosis of moderate to severe Ankylosing Spondylitis (AS) with prior documented radiologic evidence fulfilling the Modified New York criteria for AS
- Active AS assessed by total Bath Ankylosing Spondylitis Disease Activity index (BASDAI) ≥ 4 (0-10) at baseline
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm) at baseline
- 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dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications
- Stable dose of NSAIDs including Cyclooxygenase-1 (COX-1) or Cyclooxygenase-2 (COX-2) inhibitors for at least 2 weeks before their Baseline Visit
- 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
- Total ankylosis of the spine
- Use of other investigational drugs within 5 half-lives of enrollment, or within 4 weeks before the Baseline Visit, whichever is longer.
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- 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.
- 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
- Patients who have taken more than one anti-TNFα agent
- Any intramuscular or intravenous corticosteroid injection within 2 weeks before baseline
- Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline
- Previous treatment with any cell-depleting therapies
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine)
Other protocol-defined inclusion/exclusion criteria may apply.
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
- Masking Description
- Patients and Investigators will be blinded to the secukinumab dose during Treatment Period 2.
|Patients achieving an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score <1.3) at both Week 12 and Week 16.||
|Patients who have active disease, defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) total score of >1.3 at both Week 12 and Week 16, and who do achieve a decrease (improvement) from baseline in total ASDAS score at both Week 12 and Week 16.||
|Patients who exhibit no change or an increase (worsening) from baseline in total Ankylosing Spondylitis Disease Activity Score (ASDAS) score at either Week 12 or Week 16. Non-responders will not enter Treatment Period 2. Non-responders will be discontinued from the study at Week 16.||
- Novartis Pharmaceuticals
Study ContactNovartis Pharmaceuticals