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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-radiographic Axial Spondyloarthritis
• Intervention / Treatment: Drug: Secukinumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• China
  • Beijing, China, 100050
    • Novartis Investigative Site
  • Beijing, China, 100000
    • Novartis Investigative Site
  • Bengbu, China, 233004
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Shanghai, China, 200052
    • Novartis Investigative Site
  • Tianjin, China, 300052
    • Novartis Investigative Site
  • Zhejiang, China, 315016
    • Novartis Investigative Site
  • Anhui
    • Hefei, Anhui, China, 230001
      • Novartis Investigative Site
    • Hefei, Anhui, China, 230601
      • Novartis Investigative Site
  • Beijing
    • Beijing, Beijing, China, 100044
      • Novartis Investigative Site
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510515
      • Novartis Investigative Site
    • Shantou, Guangdong, China, 515041
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518020
      • Novartis Investigative Site
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410011
      • Novartis Investigative Site
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014010
      • Novartis Investigative Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Novartis Investigative Site
    • Nanjing, Jiangsu, China, 210009
      • Novartis Investigative Site
    • Yangzhou, Jiangsu, China, 225001
      • Novartis Investigative Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Novartis Investigative Site
    • Pingxiang, Jiangxi, China, 337000
      • Novartis Investigative Site
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • Novartis Investigative Site
  • Shandong
    • Linyi, Shandong, China, 276000
      • Novartis Investigative Site
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • Novartis Investigative Site
  • Yun Nan
    • KunMing, Yun Nan, China, 650000
      • Novartis Investigative Site
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
The change from baseline in sacroiliac joint (SIJ) edema on MRI.	MRI assessment of edema score of the Sacroiliac Joint.	Week 16
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): April 8, 2024
• Study Completion (Estimated): February 6, 2025

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: AIN457; chronic inflammatory disease; secukinumab; non-radiographic spondyloarthritis; inflammatory back pain,
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
• Other Study ID Numbers: CAIN457I2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No