A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07133633
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Radiographic Axial Spondyloarthritis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tulisokibart — DRUGSubcutaneous (SC) administration
- Placebo — DRUGSC administration
Study Details
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 Dates
- Start date
- Sep 26, 2025
- Status verified
- May 2026
- Primary completion
- Jun 15, 2027
- Completion
- Feb 5, 2030
Study Design
- Enrollment
- 315 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: High-dose tulisokibartParticipants receive a high dose of tulisokibart.
- Experimental: Medium-dose tulisokibartParticipants receive a medium dose of tulisokibart.
- Experimental: Low-dose tulisokibartParticipants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.
- Placebo Comparator: PlaceboParticipants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Primary Outcome Measure
Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16 [ Time Frame: Week 16 ]
Central Contacts
- Toll Free Number1-888-577-8839