Last updated 3 days ago
A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
315 patients around the world
Available in United States, Colombia
This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term
Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional
Extension.
Merck Sharp & Dohme LLC
2Research sites
315Patients around the world
This study is for people with
Axial Spondyloarthritis
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Clínica de la Costa - Barranquilla
Recruiting
CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas) - Bogotá
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07133633
