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

Condition(s) studied

Investigational drug(s) / intervention(s)

Tulisokibart: Subcutaneous (SC) administration

Placebo: SC administration

Study 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.

Eligibility

Primary outcome measure(s)

• Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16 — Week 16
  ASAS 40 is defined as a relative improvement of ≥40% and an absolute improvement of ≥2 units from baseline in ≥3 of 4 domains, with no deterioration in the fourth domain. The 4 domains include Patient Global Assessment (PtGA), total spinal pain, physical function, and morning stiffness. Each domain is measured on a 10-point numeric scale from 0 = no disease symptoms/impact to 10 = extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Trial sites (105)

+ 65 more sites — see the full list on the official registry below.