A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis
NCT05303285 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-01-27
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)
Interventions
- DRUG
-
Secukinumab 300mg s.c.
Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 300 mg secukinumab s.c. every 4 weeks
- DRUG
-
Secukinumab 150mg s.c.
Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 150 mg secukinumab s.c. every 4 weeks
Sponsors & Collaborators
-
Wuhan Central Hospital
collaborator OTHER -
Wuhan Hospital of Traditional Chinese Medicine
collaborator OTHER - collaborator INDUSTRY
-
Johns Hopkins Bloomberg School of Public Health
collaborator OTHER -
Tongji Hospital
lead OTHER
Principal Investigators
-
AIHUA DU, M.D · Tongji Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-14
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- China
Study Locations
More Related Trials
-
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
NCT02750592 ·Status: COMPLETED ·Phase: PHASE3
-
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
NCT01358175 ·Status: COMPLETED ·Phase: PHASE3
-
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
NCT01649375 ·Status: COMPLETED ·Phase: PHASE3
-
Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
NCT06905288 ·Status: RECRUITING
-
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT03259074 ·Status: COMPLETED ·Phase: PHASE3
-
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
NCT02008916 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
NCT04156620 ·Status: COMPLETED ·Phase: PHASE3
-
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
NCT06833112 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active AS
NCT05212051 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
NCT02696031 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)
NCT05861102 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Influencing Factors of Secukinumab in Patients With Axial Spondyloarthritis
NCT07130331 ·Status: COMPLETED
-
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
NCT02404350 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Ankylosing Spondylitis
NCT04481139 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
NCT05861128 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
NCT05242588 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
NCT05622708 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis
NCT01114880 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Efficacy, Safety, and Pharmacokinetic Profile and Immunogenicity of Subcutaneous Netakimab in Chinese Adult Patients With Active Ankylosing Spondylitis
NCT07277179 ·Status: COMPLETED ·Phase: PHASE3
-
Vunakizumab in Adults with Spondyloarthritis
NCT06770088 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
NCT05155098 ·Status: COMPLETED
-
A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
NCT06378697 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
NCT05467995 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
NCT05206591 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
NCT07261644 ·Status: RECRUITING ·Phase: PHASE3