Actively Recruiting
A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis
Led by Tongji Hospital · Updated on 2026-01-27
100
Participants Needed
3
Research Sites
115 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
W
Wuhan Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of ankylosing spondylitis (AS) meeting modified New York criteria
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of 4 or higher
- Patient's Assessment of Total Back Pain score of 4 or higher on a 0-10 scale
- Inadequate response to at least two NSAIDs over at least 4 weeks or intolerance/contraindication to NSAIDs
- Stable dose of methotrexate (<= 25 mg/week), sulfasalazine (<= 3 g/day), hydroxychloroquine (<= 400 mg/day), or leflunomide (<= 20 mg/day) for at least 28 days if used
- Stable dose of oral corticosteroids (prednisone <= 10 mg/day) for at least 14 days if used
- Stable dose of NSAIDs, tramadol, combination acetaminophen and codeine or hydrocodone, or non-opioid analgesics for at least 14 days if used
You will not qualify if you...
- Prior use of any Janus kinase (JAK) inhibitor
- Prior use of any biologic therapy affecting spondyloarthritis
- Joint injections or systemic corticosteroids within 28 days prior to baseline
- Use of disallowed DMARDs, thalidomide, or apremilast within 28 days or five half-lives prior to baseline
- Use of opioid analgesics (except certain combinations) or inhaled marijuana within 14 days prior to baseline
- History of other inflammatory arthritis types or arthritis onset before age 17
- Abnormal laboratory values including elevated liver enzymes, low kidney function, or low blood cell counts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of RheumatologyTongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
2
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
3
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Y
YU YIKAI, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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