Actively Recruiting
A Multicenter Study Evaluating the Efficacy and Safety 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
N/A
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
W
Wuhan Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of secukinumab 300 mg in Chinese adults with active ankylosing spondylitis (AS) who have not responded well or cannot tolerate at least two non-steroidal anti-inflammatory drugs (NSAIDs) and who have not previously used biologic disease-modifying anti-rheumatic drugs (bDMARDs). This Phase 4 study aims to understand how this treatment works in this specific patient group. The study has two parts: a 16-week period where participants are randomly assigned to receive either secukinumab 300 mg or a placebo in a double-blind setup, followed by a 52-week open-label extension where all participants receive secukinumab 300 mg. The treatment starts with weekly injections of 150 mg for five weeks, then continues with maintenance injections of either 150 mg or 300 mg every four weeks for up to 48 weeks. Participants will undergo various evaluations including disease activity scores, MRI scans, quality of life assessments, and functional indexes at baseline and throughout the study, particularly at weeks 24 and 48. Researchers will monitor the percentage of participants achieving specific responses to treatment and observe changes in disease activity and work productivity. The total study duration is approximately 68 weeks, allowing for long-term safety and efficacy monitoring.
CONDITIONS
Brief 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...
- Diagnosis of ankylosing spondylitis (AS) meeting the modified New York criteria
- BASDAI score of 4 or higher and Total Back Pain score of 4 or higher at screening and baseline
- Inadequate response to at least two NSAIDs over at least 4 weeks, or intolerance/contraindication to NSAIDs
- Stable dose of methotrexate (up to 25 mg/week), sulfasalazine (up to 3 g/day), hydroxychloroquine (up to 400 mg/day), or leflunomide (up to 20 mg/day) for at least 28 days before baseline if used
- Stable dose of oral corticosteroids (prednisone 10 mg/day or less) for at least 14 days before baseline if used
- Stable dose of NSAIDs, tramadol, acetaminophen/codeine or hydrocodone, or non-opioid analgesics for at least 14 days before baseline if used
You will not qualify if you...
- Previous use of any Janus kinase (JAK) inhibitors
- Previous use of any biologic therapy affecting spondyloarthritis
- Joint injections or parenteral corticosteroids within 28 days before baseline (inhaled or topical corticosteroids allowed)
- Use of other DMARDs (except allowed ones), thalidomide, or apremilast within 28 days or five half-lives before baseline
- Use of opioid analgesics (except allowed combinations) or inhaled marijuana within 14 days before baseline
- History of inflammatory arthritis other than axial spondyloarthritis or arthritis starting before age 17
- Certain abnormal lab values such as elevated liver enzymes, low kidney function, low blood counts as specified in screening period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive weekly injections of secukinumab 150 mg for 5 weeks, followed by maintenance injections every 4 weeks of either secukinumab 300 mg or 150 mg, depending on their assigned group.
Weekly visits for 5 weeks, then visits every 4 weeks until Week 16
Duration - 36 weeks
Participants who completed the initial 16-week period continue receiving secukinumab injections every 4 weeks for an additional 36 weeks.
Visits every 4 weeks
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
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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