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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

Key facts

Study ID

NCT03259074

Run by

Novartis Pharmaceuticals

People needed

859

Starts

2017-11-30

Expected to finish

2021-11-29

Last updated by the study team

2023-08-21

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 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Escondido, California, United States
• Novartis Investigative Site — La Mesa, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Gainesville, Florida, United States
• Novartis Investigative Site — Boise, Idaho, United States
• Novartis Investigative Site — Shreveport, Louisiana, United States
• Novartis Investigative Site — Wheaton, Maryland, United States
• Novartis Investigative Site — Great Falls, Montana, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Dayton, Ohio, United States
• Novartis Investigative Site — Middleburg Heights, Ohio, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Duncansville, Pennsylvania, United States
• Novartis Investigative Site — Memphis, Tennessee, United States
• Novartis Investigative Site — Mesquite, Texas, United States
• Novartis Investigative Site — Kennewick, Washington, United States
• Novartis Investigative Site — Franklin, Wisconsin, United States
• Novartis Investigative Site — Ciudad Autonoma de Bs As, Argentina
• Novartis Investigative Site — Malvern East, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Genk, Belgium
• Novartis Investigative Site — Winnipeg, Manitoba, Canada
• Novartis Investigative Site — Barrie, Ontario, Canada
• Novartis Investigative Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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