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

RecruitingPhase 2

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)

Who can join

Ages 18 to 80 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 315 · Started: Sep 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07133633

Locations in the U.S.

ArizonaAARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036), Chandler
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021), Flagstaff
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022), Gilbert
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056), Glendale
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025), Tucson
CaliforniaProvidence Medical Foundation ( Site 0049), Fullerton
Newport Huntington Medical Group ( Site 0005), Huntington Beach
Cohen Medical Centers ( Site 0034), Thousand Oaks
Inland Rheumatology Clinical Trials, Inc. ( Site 0002), Upland
FloridaArthritis and Rheumatic Disease Specialties ( Site 0016), Aventura
Bay Area Arthritis and Osteoporosis ( Site 0041), Brandon
GNP Research - Hollywood ( Site 0020), Cooper City
Innovation Medical Research Center ( Site 0012), Palmetto Bay
IllinoisChicago Arthritis & Regenerative Medicine ( Site 0042), Chicago
Willow Rheumatology and Wellness, PLLC ( Site 0035), Willowbrook
MarylandJohn Hopkins University ( Site 0052), Baltimore
Arthritis and Rheumatism Associates - Rockville ( Site 0019), Rockville
MissouriKansas City Physician Partners ( Site 0027), Kansas City
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038), St Louis
MontanaLogan Health Rheumatology ( Site 0015), Kalispell
NebraskaPhysician Research Collaboration, LLC ( Site 0057), Lincoln
New MexicoInspire Santa Fe Medical Group ( Site 0011), Santa Fe
OregonOregon Health & Science University ( Site 0059), Portland
PennsylvaniaAltoona Center for Clinical Research ( Site 0004), Duncansville
Perelman Center for Advanced Medicine ( Site 0060), Philadelphia
TennesseeAARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029), Murfreesboro
TexasRheumatology Associates ( Site 0055), Arlington
Arthritis Care of Texas ( Site 0048), Corpus Christi
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028), Fort Worth
Provecta Research Network LLC ( Site 0054), Houston
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032), Irving
Epic Medical Research ( Site 0061), Red Oak
Advanced Rheumatology of Houston ( Site 0001), The Woodlands
DM Clinical Research - TRA ( Site 0010), Tomball

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.