Clinical Trials List
2025-09-16 - 2031-12-31
Phase II
Recruiting7
ICD-10M08.1
Juvenile ankylosing spondylitis
ICD-10M45.0
Ankylosing spondylitis of multiple sites in spine
ICD-10M45.1
Ankylosing spondylitis of occipito-atlanto-axial region
ICD-10M45.2
Ankylosing spondylitis of cervical region
ICD-10M45.3
Ankylosing spondylitis of cervicothoracic region
ICD-10M45.4
Ankylosing spondylitis of thoracic region
ICD-10M45.5
Ankylosing spondylitis of thoracolumbar region
ICD-10M45.6
Ankylosing spondylitis lumbar region
ICD-10M45.7
Ankylosing spondylitis of lumbosacral region
ICD-10M45.8
Ankylosing spondylitis sacral and sacrococcygeal region
ICD-10M45.9
Ankylosing spondylitis of unspecified sites in spine
ICD-10M48.8X1
Other specified spondylopathies, occipito-atlanto-axial region
ICD-10M48.8X2
Other specified spondylopathies, cervical region
ICD-10M48.8X3
Other specified spondylopathies, cervicothoracic region
ICD-10M48.8X4
Other specified spondylopathies, thoracic region
ICD-10M48.8X5
Other specified spondylopathies, thoracolumbar region
ICD-10M48.8X6
Other specified spondylopathies, lumbar region
ICD-10M48.8X7
Other specified spondylopathies, lumbosacral region
ICD-10M48.8X8
Other specified spondylopathies, sacral and sacrococcygeal region
ICD-10M48.8X9
Other specified spondylopathies, site unspecified
ICD-9720.0
Ankylosing spondylitis
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 蔡弘正 Division of Rheumatology
- Wei-Sheng Chen Division of Rheumatology
- C. D. CHOU Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHIEH-YU SHEN Division of General Internal Medicine
- SONG-CHOU HSIEH Division of General Internal Medicine
- 郭佑民 Division of General Internal Medicine
- 呂政勳 Division of General Internal Medicine
- 劉津秀 Division of General Internal Medicine
- 藍鼎淵 Division of General Internal Medicine
- KO-JEN LI Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 高瑞鴻 風濕免疫科
- Yu-Sheng Chang 風濕免疫科
- 蘇勤方 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yao-Fan Fang Division of General Internal Medicine
- 吳振德 Division of Radiology
- 張哲慈 Division of General Internal Medicine
- 陳彥輔 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
The main inclusion criteria include but are not limited to the following:
Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset <45 years
Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening
Has active disease at Screening and Randomization
Has a history of inadequate response (IR)/intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR/intolerance to up to a maximum of 2 bDMARD classes
Exclusion Criteria
The main exclusion criteria include but are not limited to the following:
Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA
Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
Has any active infection
Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Ages Eligible for Study
18 Years to 80 Years (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
The Estimated Number of Participants
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Taiwan
21 participants
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Global
315 participants
