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

Non-radiographic Axial Spondyloarthritis Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04732117
• Other study ID #: CAIN457I2301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 21, 2021
• Est. completion date: February 6, 2025

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: February 6, 2025
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 TNFa 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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Non-Radiographic Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Novartis Investigative Site	Baotou	Inner Mongolia
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Bengbu
China	Novartis Investigative Site	Chang Chun	Jilin
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Hefei	Anhui
China	Novartis Investigative Site	Hefei	Anhui
China	Novartis Investigative Site	KunMing	Yun Nan
China	Novartis Investigative Site	Linyi	Shandong
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Pingxiang	Jiangxi
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shantou	Guangdong
China	Novartis Investigative Site	Shenzhen	Guangdong
China	Novartis Investigative Site	Tianjin
China	Novartis Investigative Site	Urumqi	Xinjiang
China	Novartis Investigative Site	Wenzhou	Zhejiang
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Xiamen	Fujian
China	Novartis Investigative Site	Yangzhou	Jiangsu
China	Novartis Investigative Site	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of TNF-a naive participants achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria).	ASAS40 response is defined as an improvement of; 40% and an absolute improvement from baseline of; 2 units on a 10-point scale in at least three of the four main domains and no worsening assessed at all in the remaining domain.; Main ASAS domains: Patient's global assessment of disease activity measured on a VAS scale; Patient's assessment of back pain, represented by either total or nocturnal pain scores, both measured on a VAS scale; Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by VAS scale; Inflammation represented by mean duration and severity of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI as measured by VAS scale	Week 16
Secondary	The proportion of overall participants achieving an ASAS40 response.	ASAS40 response is defined as an improvement of; 40% and an absolute improvement from baseline of; 2 units on a 10-point scale in at least three of the four main domains and no worsening assessed at all in the remaining domain.	Week 16
Secondary	The proportion of participants meeting the ASAS 5/6 response criteria.	ASAS 5/6 response is defined as an improvement of; =20% in at least five of all six domains.	Week 16
Secondary	The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).	The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS.	Week 16
Secondary	The proportion of participants achieving BASDAI 50.	BASDAI 50 is defined as an improvement of at least 50% in the BASDAI total score compared to baseline.	Week 16
Secondary	The change from baseline of high sensitivity C-Reactive Protein (hsCRP).	High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study	Week 16
Secondary	The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).	The BASFI (Bath Ankylosing Spondylitis Functional Index) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS.	Week 16
Secondary	The change from baseline in sacroiliac joint (SIJ) edema on MRI.	MRI assessment of edema score of the Sacroiliac Joint.	Week 16
Secondary	The proportion of participants achieving an ASAS20 response.	ASAS20 response is defined as an improvement of; =20% and an absolute improvement from baseline of =1 unit on a 10-point scale in at least three of the four main domains and no worsening of =20% and =1 unit at all in the remaining domain.	Week 16
Secondary	The change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS).	The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions.	Week 16
Secondary	The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.	The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis.	Week 16
Secondary	The proportion of participants achieving ASAS partial remission.	ASAS partial remission is defined as a value not above 2 units in each of the four main ASAS domains on a 10-point scale.	Week 16
Secondary	overall safety and tolerability of secukinumab.	Number of participants with adverse events (AE) serious adverse events (SAE), clinically significant changes in laboratory value and vital signs.	up to Week 52