Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-radiographic Spondyloarthritis

In brief

The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Key facts

Study ID

NCT02696031

Run by

Novartis Pharmaceuticals

People needed

555

Starts

2016-04-29

Expected to finish

2021-03-11

Last updated by the study team

2022-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
• objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
• active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
• Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
• Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
• Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
• Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response

You may not qualify if…

• Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
• Inability or unwillingness to undergo MRI
• Chest X-ray or MRI with evidence of ongoing infectious or malignant process
• Patients taking high potency opioid analgesics
• Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
• Pregnant or nursing (lactating) women

Where it is running

• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Fullerton, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Idaho Falls, Idaho, United States
• Novartis Investigative Site — Bowling Green, Kentucky, United States
• Novartis Investigative Site — Lansing, Michigan, United States
• Novartis Investigative Site — Great Falls, Montana, United States
• Novartis Investigative Site — Albany, New York, United States
• Novartis Investigative Site — Potsdam, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Charleston, South Carolina, United States
• Novartis Investigative Site — Leander, Texas, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Coffs Harbour, New South Wales, Australia
• Novartis Investigative Site — Maroochydore, Queensland, Australia
• Novartis Investigative Site — Hobart, Tasmania, Australia
• Novartis Investigative Site — Malvern East, Victoria, Australia
• Novartis Investigative Site — Woolloongabba, Australia
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.