Shelby Research

Ankylosing Spondylitis ASLeap Trial

ASLeap Trial
for 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 (ASLeap)

Trial Details

This clinical research is sponsored by the pharmaceutical company named Novartis. The purpose of this study is to estimate the difference in clinical response between 300mg and 150mg of secukinumab at Week 52, which follows randomization to dose escalation at Week 16 for patiens with Ankylosing Spondylitis who inadequately respond to open-label secukinumab 150mg. This study will also investigate the association between treatment and sleep disturbances, as well as daytime active patterns.

Secukinumab is FDA approved for only 150mg in ankylosing spondylitis, with no current studies having evaluated 300 mg as a starting dose by the approved s.c. loading regimen. Studies are also lacking in which a dose escalation to 300mg is made in response to not achieving a pre-established target clinical response on 150mg, such as disease remission, to evaluate the impact of increase dose on subsequent clinical outcomes, for which the present study aims to assess.

Inclusion Criteria

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dose for at least 4 weeks prior to their Baseline Visit, with an inadequate response or for less than 4 weeks if withdrawn for intolerance, toxicity or contraindications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

Exclusion Criteria

  • 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

View Trial on ClinicalTrials.gov website: CAIN457FUS06