Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications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

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
Patients and Investigators will be blinded to the secukinumab dose during Treatment Period 2.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Responders
Patients achieving an Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (total score <1.3) at both Week 12 and Week 16.
  • Drug: 150 mg open-label secukinumab
    All patients in Treatment Period 1 will receive 150 mg open-label secukinumab.
    Other names:
    • AIN457
  • Drug: 150 mg double-blinded secukinumab
    Treatment Period 2
    Other names:
    • AIN457
Active Comparator
Inadequate responders
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.
  • Drug: 150 mg open-label secukinumab
    All patients in Treatment Period 1 will receive 150 mg open-label secukinumab.
    Other names:
    • AIN457
  • Drug: 150 mg double-blinded secukinumab
    Treatment Period 2
    Other names:
    • AIN457
  • Drug: 300 mg double-blinded secukinumab
    Treatment Period 2
    Other names:
    • AIN457
Active Comparator
Non-responders
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.
  • Drug: 150 mg open-label secukinumab
    All patients in Treatment Period 1 will receive 150 mg open-label secukinumab.
    Other names:
    • AIN457

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.