Tests tulisokibart for radiographic axial spondyloarthritis, a type of arthritis
Tests tulisokibart against placebo in adults with spine and pelvis arthritis.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Barnet, Bath, Bradford, and Norwich, United KingdomSee the 4 sitesAlso in 13 other countries, 104 sites
- Trial code
- NCT07133633
- EU 2025-521059-21-00
- U1111-1318-5807
- Registry title
- A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 315 people, planned
- Started
- 26 Sept 2025
- Expected to end
- 5 Feb 2030
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tulisokibart
- Placebo
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with radiographic axial spondyloarthritis (ankylosing spondylitis) who have active disease. They must have had a poor response to, or could not tolerate, NSAID pain medicines.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Radiographic axial spondyloarthritis (ankylosing spondylitis) with damage that shows on X-ray, active disease at screening and at randomization, and at least 3 months of back pain with symptoms starting before age 45.
- Earlier treatment
- Poor response to, or intolerance of, NSAIDs. Either no earlier biologic DMARD, or poor response to or intolerance of up to 2 classes of biologic DMARDs.
Main reasons for not taking part
- Any arthritis starting before age 17, or another inflammatory joint disease such as rheumatoid arthritis, lupus or psoriatic arthritis
- Cancer in the last 5 years (except fully treated non-melanoma skin cancer or cervical carcinoma in situ)
- Any active infection
- Known allergy or intolerance to tulisokibart or its ingredients
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- The main exclusion criteria include but are not limited to the following:
Where in United Kingdom
Also in 13 other countries, 104 sites
- Barnet Hospital (Site 1806)Barnet, United KingdomNo longer taking part
- Royal United Hospital Bath NHS Foundation Trust (Site 1803)Bath, United KingdomNo longer taking part
- St Luke's Hospital (Site 1801)Bradford, United KingdomNo longer taking part
- Norfolk & Norwich University Hospital NHS Foundation Trust (Site 1800)Norwich, United KingdomNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- High-dose tulisokibartTreatment being tested
Participants receive a high dose of tulisokibart.
Treatment: Tulisokibart
- Medium-dose tulisokibartTreatment being tested
Participants receive a medium dose of tulisokibart.
Treatment: Tulisokibart
- Low-dose tulisokibartTreatment being tested
Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Treatment: Tulisokibart
- PlaceboPlacebo, for comparison
Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests tulisokibart for radiographic axial spondyloarthritis, a type of arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 12 November 2026