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Active, not recruitingPhase 2

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
Arlington, Aventura, Baltimore, Brandon, Brooklyn, Chandler, Chicago, Chula Vista, Cooper City, Corpus Christi, Denver, Duncansville, Flagstaff, Fort Worth, Fullerton, Gilbert, Glendale, Houston, Huntington Beach, Irving, Kalispell, Kansas City, Lincoln, Murfreesboro, Palmetto Bay, Philadelphia, Portland, Red Oak, Rockville, Santa Fe, St Louis, The Woodlands, Thousand Oaks, Tomball, Tucson, Upland, and Willowbrook, United StatesSee the 38 sitesAlso in 13 other countries, 70 sites
Trial code
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 States

Also in 13 other countries, 70 sites

  • Rheumatology Associates (Site 0055)Arlington, United States
  • Arthritis and Rheumatic Disease Specialties (Site 0016)Aventura, United States
  • John Hopkins University (Site 0052)Baltimore, United States
  • Bay Area Arthritis and Osteoporosis (Site 0041)Brandon, United States
  • Joseph S. and Diane H. Steinberg Ambulatory Care Center (Site 0063)Brooklyn, United States
  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler (Site 0036)Chandler, United States
  • Chicago Arthritis & Regenerative Medicine (Site 0042)Chicago, United States
  • TriWest Research Associates - Chula Vista (Site 0013)Chula Vista, United States
  • GNP Research - Hollywood (Site 0020)Cooper City, United States
  • Arthritis Care of Texas (Site 0048)Corpus Christi, United States
  • Denver Arthritis Clinic (Site 0064)Denver, United States
  • Altoona Center for Clinical Research (Site 0004)Duncansville, United States
  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff (Site 0021)Flagstaff, United States
  • Lone Star Arthritis & Rheumatology Associates, P.C. (Site 0028)Fort Worth, United States
  • Providence Medical Foundation (Site 0049)Fullerton, United States
  • Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert (Site 0022)Gilbert, United States
  • AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale (Site 0056)Glendale, United States
  • Provecta Research Network LLC (Site 0054)Houston, United States
  • The University of Texas Health Science Center at Houston (Site 0065)Houston, United States
  • Newport Huntington Medical Group (Site 0005)Huntington Beach, United States
  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving (Site 0032)Irving, United States
  • Logan Health Rheumatology (Site 0015)Kalispell, United States
  • Kansas City Physician Partners (Site 0027)Kansas City, United States
  • Physician Research Collaboration, LLC (Site 0057)Lincoln, United States
  • AARA Clinical Research - Murfreesboro Medical Clinic (Site 0029)Murfreesboro, United States
  • Innovation Medical Research Center (Site 0012)Palmetto Bay, United States
  • Perelman Center for Advanced Medicine (Site 0060)Philadelphia, United States
  • Oregon Health & Science University (Site 0059)Portland, United States
  • Epic Medical Research (Site 0061)Red Oak, United States
  • Arthritis and Rheumatism Associates - Rockville (Site 0019)Rockville, United States
  • Inspire Santa Fe Medical Group (Site 0011)Santa Fe, United States
  • Velocity Clinical Research - West County Rheumatology, St. Louis (Site 0038)St Louis, United States
  • Advanced Rheumatology of Houston (Site 0001)The Woodlands, United States
  • Cohen Medical Centers (Site 0034)Thousand Oaks, United States
  • DM Clinical Research - TRA (Site 0010)Tomball, United States
  • Arizona Arthritis & Rheumatology Associates, P.C. - Tucson (Site 0025)Tucson, United States
  • Inland Rheumatology Clinical Trials, Inc. (Site 0002)Upland, United States
  • Willow Rheumatology and Wellness, PLLC (Site 0035)Willowbrook, United States

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