What is tulisokibart studying for radiographic axial spondyloarthritis?

Tulisokibart is being studied to see if it can improve symptoms of radiographic axial spondyloarthritis, a type of arthritis affecting the spine and pelvis. The trial compares different doses of tulisokibart to a placebo to understand its effects better. Merck Sharp & Dohme LLC is sponsoring this research.

Who may be eligible for this radiographic axial spondyloarthritis clinical trial?

Adults aged 18 to 80 with a diagnosis of axial spondyloarthritis and back pain starting before age 45 may be eligible. Participants must have active disease and a history of inadequate response or intolerance to certain arthritis treatments. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this radiographic axial spondyloarthritis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Age: 18Years - 80Years

All Genders

ID07133633

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

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29

315

Participants Needed

100

Research Sites

138 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring new treatments for radiographic axial spondyloarthritis r-axSpA, a type of arthritis causing pain, stiffness, and swelling in the spine and pelvic joints. This study aims to find out if different doses of tulisokibart, a study medicine, can improve symptoms of r-axSpA better than a placebo. A placebo looks like the medicine but contains no active drug, helping researchers understand tulisokibarts effects. Participants will be randomly assigned to receive either a high, medium, or low dose of tulisokibart, or a placebo, all given by subcutaneous injection. The study includes a 16-week placebo-controlled period followed by a 124-week long-term extension, which has a 40-week main extension and an 84-week optional extension. Participants on low dose or placebo will be rerandomized at week 16 to medium or high doses of tulisokibart. During the study, participants will undergo regular assessments including symptom evaluations, physical function tests, and MRI scans at the start and week 16. Researchers will track response rates, changes in disease activity, pain levels, and quality of life measures. Safety will be monitored throughout, and the study lasts up to about 140 weeks. The main outcome is the percentage of participants achieving a significant improvement in symptoms at week 16.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Clinical diagnosis of axial spondyloarthritis meeting ASAS criteria with at least 3 months of back pain and symptom onset before age 45
Meets modified New York criteria for ankylosing spondylitis confirmed by central reading
Active disease at screening and randomization
History of inadequate response or intolerance to NSAIDs
Biologic disease-modifying antirheumatic drug (bDMARD) naive or inadequate response/intolerance to up to 2 bDMARD classes

You will not qualify if you...

Arthritis onset before age 17 or diagnosis of other inflammatory joint diseases besides r-axSpA
History of cancer within last 5 years except certain treated skin or cervical cancers
Any active infection
Known allergies or intolerance to tulisokibart or its ingredients

Research Team

Toll Free Number

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here