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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Radiographic Axial Spondyloarthritis

Treatments: Drug: Placebo; Drug: Tulisokibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07133633

2025-521059-21-00 (Registry Identifier)

U1111-1318-5807 (Registry Identifier)

MK-7240-013 (Other Identifier)

7240-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 315 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

315 participants in 4 patient groups, including a placebo group

High-dose tulisokibart

Experimental group

Description:

Participants receive a high dose of tulisokibart.

Treatment:

Drug: Tulisokibart

Medium-dose tulisokibart

Experimental group

Description:

Participants receive a medium dose of tulisokibart.

Treatment:

Drug: Tulisokibart

Low-dose tulisokibart

Experimental group

Description:

Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.

Treatment:

Drug: Tulisokibart

Placebo

Placebo Comparator group

Description:

Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.

Treatment:

Drug: Placebo