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

Status:	Active, not recruiting
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - Any
Updated:	1/11/2019
Start Date:	April 29, 2016
End Date:	December 16, 2020

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

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 followed by an optional 16-week randomized dose escalation treatment
period and a continuous treatment period for up to Week 208

Inclusion Criteria:

- 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 TNFα inhibitor (not more than one) must have experienced
an inadequate response

Exclusion Criteria:

- 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

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

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A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

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