Status:
COMPLETED
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-radiographic Axial Spondyloarthritis
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate efficacy, safety and tolerability of secukinumab in Chinese patients with active nr-axSpA. Treatment difference of secukinumab 150mg vs. placebo in Chinese nr-...
Eligibility Criteria
Inclusion
- 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
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04732117
Start Date
July 21 2021
End Date
February 14 2025
Last Update
March 5 2025
Active Locations (29)
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1
Novartis Investigative Site
Hefei, Anhui, China, 230001
2
Novartis Investigative Site
Hefei, Anhui, China, 230601
3
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100044
4
Novartis Investigative Site
Xiamen, Fujian, China, 361001