A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

NCT05303285 | Recruiting Phase 4

• 1 other identifier: Tongji0228
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of secukinumab 300mg in Chinese adults participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

Conditions

Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24

  ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

  24 weeks

Secondary Outcomes (12)

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48

  Baseline and Week 48

• Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 48

  Baseline and Week 48

• Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 48

  Baseline and Week 48

• Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score

  Baseline and Week 48

• Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission

  Baseline and Week 48

Study Arms (2)

Secukinumab 300mg

EXPERIMENTAL

Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 300 mg s.c. every 4 weeks for an additional 48 weeks.

Drug: Secukinumab 300mg s.c.

Secukinumab 150 mg

ACTIVE COMPARATOR

Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks for an additional 48 weeks.

Drug: Secukinumab 150mg s.c.

Interventions

Secukinumab 300mg s.c. DRUG

Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 300 mg secukinumab s.c. every 4 weeks

Also known as: AIN457, Cosentyx

Secukinumab 300mg

Secukinumab 150mg s.c. DRUG

Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 150 mg secukinumab s.c. every 4 weeks

Also known as: AIN457, Cosentyx

Secukinumab 150 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
• Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of ●Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
• Participant has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
• If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (\<= 25 mg/week) and/or SSZ (\<= 3 g/day) and/or hydroxychloroquine (\<= 400 mg/day) or leflunomide (\<= 20 mg/day) for at least 28 days prior to the Baseline visit. A combination of up to two background conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and leflunomide.
• If entering the study on concomitant oral corticosteroids, participant must be on a stable dose of prednisone (\<= 10 mg/day), or oral corticosteroid equivalents, for at least 14 days prior to the Baseline visit.
• If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on stable dose(s) for at least 14 days prior to the Baseline visit.

You may not qualify if:

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any biologic therapy with a potential therapeutic impact on spondyloarthritis (SpA).
• Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral administration of corticosteroids within 28 days prior to the Baseline visit. Inhaled or topical corticosteroids are allowed.
• Participant on any other DMARDs (other than those allowed), thalidomide or apremilast within 28 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
• Participant on opioid analgesics (except for combination acetaminophen/codeine or acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14 days prior to the Baseline visit.
• Participant has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age.
• Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase \> 2 × upper limit of normal (ULN); serum alanine transaminase \> 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula \< 40 milliliter (mL)/minute/1.73m\^2; hemoglobin \< 10 gram/deciliter, total white blood cell count \< 2,500/microliter (μL); absolute neutrophil count \< 1,500/μL; absolute lymphocyte count \< 800/μL; and platelet count \< 100,000/μL.

Sponsors & Collaborators

• Tongji Hospital: lead
• Wuhan Central Hospital: collaborator
• Wuhan Hospital of Traditional Chinese Medicine: collaborator
• Novartis: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (3)

Department of RheumatologyTongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Study Officials

• AIHUA DU, M.D

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

YU YIKAI, M.D

CONTACT

15671678920; yuyikai@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 31, 2022
• Study Start: June 14, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)