Back to resultsEfficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
Primary Purpose
Non-radiographic Axial Spondyloarthritis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Secukinumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-radiographic Axial Spondyloarthritis focused on measuring non-radiographic spondyloarthritis, chronic inflammatory disease, inflammatory back pain,, secukinumab, AIN457
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.
Sites / Locations
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
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- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Secukinumab Arm
Placebo Arm
Arm Description
Secukinumab 150 mg PFS s.c.
Placebo 150mg PFS s.c.
Outcomes
Primary Outcome Measures
The proportion of TNF-α 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
Secondary Outcome Measures
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.
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.
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.
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.
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
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.
The change from baseline in sacroiliac joint (SIJ) edema on MRI.
MRI assessment of edema score of the Sacroiliac Joint.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04732117
First Posted
January 28, 2021
Last Updated
August 30, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04732117
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
July 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Axial Spondyloarthritis
Keywords
non-radiographic spondyloarthritis, chronic inflammatory disease, inflammatory back pain,, secukinumab, AIN457
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Secukinumab Arm
Arm Type
Experimental
Arm Description
Secukinumab 150 mg PFS s.c.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Placebo 150mg PFS s.c.
Intervention Type
Drug
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
AIN457 Placebo
Intervention Description
Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4.
Primary Outcome Measure Information:
Title
The proportion of TNF-α naive participants achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria).
Description
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
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
The proportion of overall participants achieving an ASAS40 response.
Description
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.
Time Frame
Week 16
Title
The proportion of participants meeting the ASAS 5/6 response criteria.
Description
ASAS 5/6 response is defined as an improvement of
≥20% in at least five of all six domains.
Time Frame
Week 16
Title
The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Description
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.
Time Frame
Week 16
Title
The proportion of participants achieving BASDAI 50.
Description
BASDAI 50 is defined as an improvement of at least 50% in the BASDAI total score compared to baseline.
Time Frame
Week 16
Title
The change from baseline of high sensitivity C-Reactive Protein (hsCRP).
Description
High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study
Time Frame
Week 16
Title
The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).
Description
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.
Time Frame
Week 16
Title
The change from baseline in sacroiliac joint (SIJ) edema on MRI.
Description
MRI assessment of edema score of the Sacroiliac Joint.
Time Frame
Week 16
Title
The proportion of participants achieving an ASAS20 response.
Description
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.
Time Frame
Week 16
Title
The change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS).
Description
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.
Time Frame
Week 16
Title
The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.
Description
The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis.
Time Frame
Week 16
Title
The proportion of participants achieving ASAS partial remission.
Description
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.
Time Frame
Week 16
Title
overall safety and tolerability of secukinumab.
Description
Number of participants with adverse events (AE) serious adverse events (SAE), clinically significant changes in laboratory value and vital signs.
Time Frame
up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10050
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chang Chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110011
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
KunMing
State/Province
Yun Nan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bengbu
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Zhejiang
ZIP/Postal Code
315016
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
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