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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04732117

Collaborator

(none)

134

Enrollment

Locations

Arms

38.4

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-radiographic Axial Spondyloarthritis	Drug: Secukinumab Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Nov 29, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Secukinumab Arm Secukinumab 150 mg PFS s.c.	Drug: Secukinumab Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, and 3, followed by administration every 4 weeks starting at Week 4. Other Names: AIN457
Placebo Comparator: Placebo Arm Placebo 150mg PFS s.c.	Drug: Placebo Placebo 150 mg s.c.at BSL, Weeks 1, 2 and 3, followed by administration every 4 weeks starting at Week 4. Other Names: AIN457 Placebo

Arm

Intervention/Treatment

Experimental: Secukinumab Arm

Secukinumab 150 mg PFS s.c.

Drug: Secukinumab

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

Other Names:

AIN457

Placebo Comparator: Placebo Arm

Placebo 150mg PFS s.c.

Drug: Placebo

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

Other Names:

AIN457 Placebo

Outcome Measures

Primary Outcome Measures

The proportion of TNF-α naive participants achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria). [Week 16]
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. [Week 16]
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. [Week 16]
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). [Week 16]
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. [Week 16]
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). [Week 16]
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). [Week 16]
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. [Week 16]
MRI assessment of edema score of the Sacroiliac Joint.
The proportion of participants achieving an ASAS20 response. [Week 16]
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). [Week 16]
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. [Week 16]
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. [Week 16]
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. [up to Week 52]
Number of participants with adverse events (AE) serious adverse events (SAE), clinically significant changes in laboratory value and vital signs.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Hefei	Anhui	China	230001
2	Novartis Investigative Site	Hefei	Anhui	China	230601
3	Novartis Investigative Site	Beijing	Beijing	China	100044
4	Novartis Investigative Site	Xiamen	Fujian	China	361001
5	Novartis Investigative Site	Guangzhou	Guangdong	China	510080
6	Novartis Investigative Site	Guangzhou	Guangdong	China	510515
7	Novartis Investigative Site	Shantou	Guangdong	China	515041
8	Novartis Investigative Site	Shenzhen	Guangdong	China	518020
9	Novartis Investigative Site	Wuhan	Hubei	China	430030
10	Novartis Investigative Site	Changsha	Hunan	China	410011
11	Novartis Investigative Site	Zhuzhou	Hunan	China
12	Novartis Investigative Site	Baotou	Inner Mongolia	China	014010
13	Novartis Investigative Site	Hohhot	Inner Mongolia	China	10050
14	Novartis Investigative Site	Nanjing	Jiangsu	China	210008
15	Novartis Investigative Site	Nanjing	Jiangsu	China	210009
16	Novartis Investigative Site	Nanjing	Jiangsu	China	210029
17	Novartis Investigative Site	Suzhou	Jiangsu	China	215004
18	Novartis Investigative Site	Yangzhou	Jiangsu	China
19	Novartis Investigative Site	Nanchang	Jiangxi	China	330006
20	Novartis Investigative Site	Pingxiang	Jiangxi	China	337000
21	Novartis Investigative Site	Chang Chun	Jilin	China	130021
22	Novartis Investigative Site	Shenyang	Liaoning	China	110011
23	Novartis Investigative Site	Linyi	Shandong	China	276000
24	Novartis Investigative Site	Urumqi	Xinjiang	China	830001
25	Novartis Investigative Site	KunMing	Yun Nan	China	650000
26	Novartis Investigative Site	Wenzhou	Zhejiang	China	325000
27	Novartis Investigative Site	Beijing		China	100000
28	Novartis Investigative Site	Beijing		China	100029
29	Novartis Investigative Site	Beijing		China	100050
30	Novartis Investigative Site	Beijing		China	100730
31	Novartis Investigative Site	Bengbu		China	233004
32	Novartis Investigative Site	Shanghai		China	200040
33	Novartis Investigative Site	Shanghai		China	200052
34	Novartis Investigative Site	Tianjin		China	300052
35	Novartis Investigative Site	Zhejiang		China