Shelby Research

Ankylosing Spondylitis SURPASS Trial

SURPASS Trial
for Ankylosing Spondylitis

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

Trial Details

This clinical research is sponsored by the pharmaceutical company named Novartis. The purpose of the study is to compare the effects of secukinumab and GP2017 (adalimumab biosimilar) on the progression of structural changes to the spine in subjects with AS. Data from this study may be used to support the addition of wording in the Cosentyx® product label regarding a potential benefit on spinal structural changes based on radiographic (X-ray) findings.

There will be three treatment arms in this study. The study is designed to compare a 150mg dose of secukinumab, a 300mg dose of secukinumab and a 40mg does of GP2017 (adalimumbab biosimilar). A pre-filled syringe with a liquid formulation of secukinumab or GP2017(adalimumbab biosimilar) will be used in this study. Study treatment (secukinumab vs GP2017 (adalimumbab biosimilar)) will be provided in an open-label fashion (you will know which of these study drugs you are taking.)

Inclusion Criteria

  • Male or non-pregnant, non-nursing female patients at least 18 years of age

  • Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy

  • Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10

  • Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)

  • Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)

  • hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion Criteria

Patients with total ankylosis of the spine

  • Pregnant or nursing (lactating) women

  • Evidence of ongoing infectious or malignant process

  • Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα

  • Subjects taking high potency opioid analgesics

  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents

*Other protocol-defined inclusion/exclusion criteria may apply

View Trial on ClinicalTrials.gov website: CAIN457K2340