Status:
RECRUITING
A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Radiographic Axial Spondyloarthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and j...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 5 2030
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT07133633
Start Date
September 26 2025
End Date
February 5 2030
Last Update
January 9 2026
Active Locations (54)
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1
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Chandler, Arizona, United States, 85225
2
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
Flagstaff, Arizona, United States, 86001
3
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
Gilbert, Arizona, United States, 85297
4
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
Glendale, Arizona, United States, 85306