A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)

Más betegség

• 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

Életkor

• 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

Egyéb

• The main exclusion criteria include but are not limited to the following:

• 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