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Tulisokibart (MK-7240) for radiographic axial spondyloarthritis

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)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT07133633

This trial will test tulisokibart (MK‑7240) in adults with radiographic axial spondyloarthritis to see if it reduces spine and pelvic joint pain and stiffness compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment315 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations98 sites (Chandler, Arizona and 97 other locations)
Trial IDNCT07133633 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with active radiographic axial spondyloarthritis meeting ASAS/modified New York criteria who have had inadequate relief from NSAIDs and are bDMARD‑naive or have failed up to two bDMARD classes.

Not a fit: Patients with inflammatory joint disease other than radiographic axial spondyloarthritis, disease onset before age 17, or extensive prior biologic treatment failures may not benefit from this study treatment.

Why it matters

Potential benefit: If successful, tulisokibart could reduce pain, stiffness, and inflammation for people with radiographic axial spondyloarthritis.

How similar studies have performed: Other targeted therapies for axial spondyloarthritis, including TNF and IL‑17 inhibitors and newer small molecules, have shown clinical benefit, so testing another targeted agent follows established approaches.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Radiographic Axial Spondyloarthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.