NCT07133633

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

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

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.

Conditions

• Radiographic Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Tulisokibart	Subcutaneous (SC) administration
DRUG	Placebo	SC administration

Timeline

• Start date: 2025-09-26
• Primary completion: 2027-06-15
• Completion: 2030-02-05
• First posted: 2025-08-21
• Last updated: 2026-04-20

Locations

95 sites across 14 countries: United States, Brazil, Canada, Chile, China, Colombia, Germany, Netherlands, Poland, South Korea, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study