A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Radiographic Axial Spondyloarthritis
In brief
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 joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays. This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart. Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
Key facts
- Study ID
- NCT07133633
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 315
- Starts
- 2025-09-26
- Expected to finish
- 2030-02-05
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021) — Flagstaff, Arizona, United States (enrolling)
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036) — Chandler, Arizona, United States (enrolling)
- AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056) — Glendale, Arizona, United States (enrolling)
- Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025) — Tucson, Arizona, United States (enrolling)
- Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022) — Gilbert, Arizona, United States (enrolling)
- Providence Medical Foundation ( Site 0049) — Fullerton, California, United States (enrolling)
- Newport Huntington Medical Group ( Site 0005) — Huntington Beach, California, United States (enrolling)
- Cohen Medical Centers ( Site 0034) — Thousand Oaks, California, United States (enrolling)
- Inland Rheumatology Clinical Trials, Inc. ( Site 0002) — Upland, California, United States (enrolling)
- Arthritis and Rheumatic Disease Specialties ( Site 0016) — Aventura, Florida, United States (enrolling)
- Bay Area Arthritis and Osteoporosis ( Site 0041) — Brandon, Florida, United States (enrolling)
- GNP Research - Hollywood ( Site 0020) — Cooper City, Florida, United States (enrolling)
- Innovation Medical Research Center ( Site 0012) — Palmetto Bay, Florida, United States (enrolling)
- Chicago Arthritis & Regenerative Medicine ( Site 0042) — Chicago, Illinois, United States (enrolling)
- Willow Rheumatology and Wellness, PLLC ( Site 0035) — Willowbrook, Illinois, United States (enrolling)
- John Hopkins University ( Site 0052) — Baltimore, Maryland, United States (enrolling)
- Arthritis and Rheumatism Associates - Rockville ( Site 0019) — Rockville, Maryland, United States (enrolling)
- Kansas City Physician Partners ( Site 0027) — Kansas City, Missouri, United States (enrolling)
- Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038) — St Louis, Missouri, United States (enrolling)
- Logan Health Rheumatology ( Site 0015) — Kalispell, Montana, United States (enrolling)
- Physician Research Collaboration, LLC ( Site 0057) — Lincoln, Nebraska, United States (enrolling)
- Inspire Santa Fe Medical Group ( Site 0011) — Santa Fe, New Mexico, United States (enrolling)
- Oregon Health & Science University ( Site 0059) — Portland, Oregon, United States (enrolling)
- Altoona Center for Clinical Research ( Site 0004) — Duncansville, Pennsylvania, United States (enrolling)
- Perelman Center for Advanced Medicine ( Site 0060) — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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