Clinical trial NCT04732117: Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-radiographic Axial Spondyloarthritis
Keywords: non-radiographic spondyloarthritis
chronic inflammatory disease
inflammatory back pain,
secukinumab
AIN457
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The proportion of TNF-α naive participants achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria).
timeFrame: Week 16
Secondary outcomes:
measure: The proportion of overall participants achieving an ASAS40 response.
timeFrame: Week 16
measure: The proportion of participants meeting the ASAS 5/6 response criteria.
timeFrame: Week 16
measure: The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
timeFrame: Week 16
measure: The proportion of participants achieving BASDAI 50.
timeFrame: Week 16
measure: The change from baseline of high sensitivity C-Reactive Protein (hsCRP).
timeFrame: Week 16
measure: The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).
timeFrame: Week 16
measure: The change from baseline in sacroiliac joint (SIJ) edema on MRI.
timeFrame: Week 16
measure: The proportion of participants achieving an ASAS20 response.
timeFrame: Week 16
measure: The change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS).
timeFrame: Week 16
measure: The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.
timeFrame: Week 16
measure: The proportion of participants achieving ASAS partial remission.
timeFrame: Week 16
measure: overall safety and tolerability of secukinumab.
timeFrame: up to Week 52
Other outcomes:
Locations:
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Xiamen
country: China
facility: Novartis Investigative Site
state: Fujian
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shantou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shenzhen
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Baotou
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Yangzhou
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Pingxiang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Chang Chun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Linyi
country: China
facility: Novartis Investigative Site
state: Shandong
city: Urumqi
country: China
facility: Novartis Investigative Site
state: Xinjiang
city: KunMing
country: China
facility: Novartis Investigative Site
state: Yun Nan
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Bengbu
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Zhejiang
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: