Tulisokibart (MK-7240) for radiographic axial spondyloarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, placebo‑controlled trial tests multiple doses of tulisokibart (MK‑7240) in adults with radiographic axial spondyloarthritis. Participants complete a 16‑week placebo‑controlled period comparing different active dose arms to placebo. Those who finish the controlled period may enter a 124‑week long‑term extension (a 40‑week main extension plus an 84‑week optional extension) to monitor longer‑term safety and durability of benefit. Key eligibility includes central confirmation of radiographic changes by the modified New York criteria and active disease, with participants either bDMARD‑naive or having failed up to two bDMARD classes.

Why it matters

Who can join: the full rules

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

Where it's running

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
  Chandler, Arizona, United States Recruiting
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
  Flagstaff, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
  Gilbert, Arizona, United States Recruiting
• AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
  Glendale, Arizona, United States Recruiting
• Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
  Tucson, Arizona, United States Recruiting
• Providence Medical Foundation ( Site 0049)
  Fullerton, California, United States Recruiting

+57 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.