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

A Randomized, Double-blind, Placebo Controlled, Multicenter 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.

ClinicalTrials.gov Identifier: NCT04732117

Novartis Reference Number: CAIN457I2301

Last Update: Feb 01, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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-axSpA patients in terms of ASAS 40 response rate as well as safety profile will be provided by the study.

Condition 
Non-radiographic Axial Spondyloarthritis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jul 21, 2021
Completion date 
Oct 01, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Secukinumab
Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4.
Drug
Placebo
Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4.

Eligibility Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

China
Novartis Investigative Site
Recruiting
Hefei, 230601
Anhui
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Guangzhou, 510080
Guangdong
China
Novartis Investigative Site
Recruiting
Guangzhou, 510515
Guangdong
China
Novartis Investigative Site
Recruiting
Shantou, 515041
Guangdong
China
Novartis Investigative Site
Recruiting
Shenzhen, 518020
Guangdong
China
Novartis Investigative Site
Recruiting
Wuhan, 430030
Hubei
China
Novartis Investigative Site
Recruiting
Zhuzhou,
Hunan
China
Novartis Investigative Site
Recruiting
Baotou, 014010
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Hohhot, 10050
Inner Mongolia
China
Novartis Investigative Site
Recruiting
Nanjing, 210008
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanjing, 210009
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanjing, 210029
Jiangsu
China
Novartis Investigative Site
Recruiting
Suzhou, 215004
Jiangsu
China
Novartis Investigative Site
Recruiting
Nanchang, 330006
Jiangxi
China
Novartis Investigative Site
Recruiting
Pingxiang, 337000
Jiangxi
China
Novartis Investigative Site
Recruiting
Chang Chun, 130021
Jilin
China
Novartis Investigative Site
Recruiting
Shenyang, 110011
Liaoning
China
Novartis Investigative Site
Recruiting
Linyi, 276000
Shandong
China
Novartis Investigative Site
Recruiting
Urumqi, 830001
Xinjiang
China
Novartis Investigative Site
Recruiting
KunMing, 650000
Yun Nan
China
Novartis Investigative Site
Recruiting
Wenzhou, 325000
Zhejiang
China
Novartis Investigative Site
Recruiting
Beijing, 100000
-
China
Novartis Investigative Site
Recruiting
Beijing, 100029
-
China
Novartis Investigative Site
Recruiting
Beijing, 100730
-
China
Novartis Investigative Site
Recruiting
Bengbu, 233004
-
China
Novartis Investigative Site
Recruiting
Shanghai, 200040
-
China
Novartis Investigative Site
Recruiting
Tianjin, 300052
-
China
Novartis Investigative Site
Recruiting
Zhejiang,
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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