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Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study was to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter, Phase III Study of Subcutaneous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Chinese Participants With Active Non-radiographic Axial Spondyloarthritis
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
137
Start Date
2021-07-21
Completion Date
2025-02-14
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Secukinumab
Secukinumab 150 mg s.c. using a PFS at Baseline, Weeks 1, 2, and 3, followed by administration every 4 weeks from Week 4 until Week 12. At Week 16, all participants continued or switched to receiving secukinumab 150 mg s.c. every 4 weeks, using a PFS. This treatment regimen continued from Week 16 through Week 48. For participants who did not respond to the secukinumab 150 mg dose during the open-label period, the dose was increased to 300 mg s.c., using two PFS, also administered every 4 weeks.
Placebo
Placebo s.c. using a PFS at baseline, Weeks 1, 2 and 3, followed by administration every 4 weeks from Week 4 until Week 12.
Locations (29)
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
Ningbo, Zhejiang, 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