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

NCT04732117 | Completed Phase 3 Results

• 1 other identifier: CAIN457I2301
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this study was to evaluate the efficacy, safety, and tolerability of secukinumab in Chinese patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

Conditions

Non-radiographic Axial Spondyloarthritis

Keywords

non-radiographic spondyloarthritis; chronic inflammatory disease; inflammatory back pain,; secukinumab; AIN457

Outcome Measures

Primary Outcomes (1)

• Assessment of SpondyloArthritis International Society 40 (ASAS40) Response Rate in TNF-alpha-inhibitor-naive Participants at Week 16

  ASAS40 response was defined as relative improvement of at least 40% and absolute improvement of at least 2 units on a 0 to 10 scale in at least 3 of the 4 main domains of the ASAS and no worsening at all in the remaining domain. The 4 main domains of the ASAS are: 1.Patient's Global Assessment of Disease Activity (score ranged from 0 \[not active\] to 10 \[very active\]); 2.Back Pain (score ranged from 0 \[no pain\] to 10 \[severe pain\]); 3.Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) (score ranged from 0 \[easy\] to 10 \[impossible\]); 4.Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) (score ranged from 0 \[none\] to 10 \[very severe\]). The percentage of TNF-alpha-inhibitor-naïve participants who achieved ASAS40 response at Week 16 was assessed using a logistic regression model. Discontinued participants and those with missing responses were considered non-responders

  Baseline, Week 16

Secondary Outcomes (11)

• ASAS40 Response Rate in All Participants at Week 16

  Baseline, Week 16

• ASAS 5/6 Response Rate at Week 16.

  Baseline, Week 16

• Change From Baseline in Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 16

  Baseline, Week 16

• BASDAI 50 Rate at Week 16

  Baseline, Week 16

• Change From Baseline of High Sensitivity C-Reactive Protein (hsCRP) at Week 16

  Baseline, Week 16

Study Arms (2)

Secukinumab

EXPERIMENTAL

Participants received secukinumab 150 mg in a pre-filled syringe (PFS). Treatment was double-blinded until Week 12. From Week 16, participants continued with an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Participants initially received a placebo in a pre-filled syringe (PFS) in a double-blinded manner until Week 12. At Week 16, they switched to an open-label treatment of secukinumab 150 mg. At Week 24, non-responders (not achieving ASAS20) were escalated to secukinumab 300 mg, while responders continued with secukinumab 150 mg.

Drug: Placebo

Interventions

Secukinumab DRUG

Secukinumab 150 mg s.c. using a PFS at Baseline, Weeks 1, 2, and 3, followed by administration every 4 weeks from Week 4 until Week 12. At Week 16, all participants continued or switched to receiving secukinumab 150 mg s.c. every 4 weeks, using a PFS. This treatment regimen continued from Week 16 through Week 48. For participants who did not respond to the secukinumab 150 mg dose during the open-label period, the dose was increased to 300 mg s.c., using two PFS, also administered every 4 weeks.

Also known as: AIN457

Secukinumab

Placebo DRUG

Placebo s.c. using a PFS at baseline, Weeks 1, 2 and 3, followed by administration every 4 weeks from Week 4 until Week 12.

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Novartis Investigative Site

Hefei, Anhui, 230001, China

Location

Novartis Investigative Site

Hefei, Anhui, 230601, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100044, China

Location

Novartis Investigative Site

Xiamen, Fujian, 361001, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510030, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510515, China

Location

Novartis Investigative Site

Shantou, Guangdong, 515000, China

Location

Novartis Investigative Site

Shenzhen, Guangdong, 518020, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150000, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Baotou, Inner Mongolia, 014010, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210008, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210009, China

Location

Novartis Investigative Site

Yangzhou, Jiangsu, 225001, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Pingxiang, Jiangxi, 337000, China

Location

Novartis Investigative Site

Changchun, Jilin, 130021, China

Location

Novartis Investigative Site

Linyi, Shandong, 276000, China

Location

Novartis Investigative Site

Ürümqi, Xinjiang, 830001, China

Location

Novartis Investigative Site

Kunming, Yunnan, 650000, China

Location

Novartis Investigative Site

Ningbo, Zhejiang, 315016, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325000, China

Location

Novartis Investigative Site

Beijing, 100000, China

Location

Novartis Investigative Site

Beijing, 100050, China

Location

Novartis Investigative Site

Bengbu, 233004, China

Location

Novartis Investigative Site

Shanghai, 200040, China

Location

Novartis Investigative Site

Shanghai, 200050, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Non-Radiographic Axial Spondyloarthritis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: July 21, 2021
• Primary Completion: April 3, 2024
• Study Completion: February 14, 2025
• Last Updated: April 9, 2026
• Results First Posted: January 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (29)