Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
NCT ID: NCT04732117
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
138 participants
INTERVENTIONAL
2021-07-21
2025-02-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Secukinumab Arm
Secukinumab 150 mg PFS s.c.
Secukinumab
Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4.
Placebo Arm
Placebo 150mg PFS s.c.
Placebo
Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4.
Interventions
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Secukinumab
Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4.
Placebo
Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Hefei, Anhui, China
Novartis Investigative Site
Hefei, Anhui, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Xiamen, Fujian, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shantou, Guangdong, China
Novartis Investigative Site
Shenzhen, Guangdong, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Novartis Investigative Site
Baotou, Inner Mongolia, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Yangzhou, Jiangsu, China
Novartis Investigative Site
Nanchang, Jiangxi, China
Novartis Investigative Site
Pingxiang, Jiangxi, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Linyi, Shandong, China
Novartis Investigative Site
Ürümqi, Xinjiang, China
Novartis Investigative Site
Kunming, Yunnan, China
Novartis Investigative Site
Wenzhou, Zhejiang, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Bengbu, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Zhejiang, , China
Countries
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Other Identifiers
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CAIN457I2301
Identifier Type: -
Identifier Source: org_study_id
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