SHS_280181 MEAP CNOV 17198

A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

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

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
Phase III
NCT03259074
All Other
Rheumatology
Philip Mease, M.D.
Novartis
Sephren Barrow
  • Swedish Medical Center