A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
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)
- Radiographic Axial Spondyloarthritis
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 315
- Started
- 26 September 2025
- Main results due
- 15 June 2027
- Study sites
- 105
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 80 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(105)
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
TriWest Research Associates - Chula Vista ( Site 0013)
Chula Vista, California, United States
Completed
Providence Medical Foundation ( Site 0049)
Fullerton, California, United States
Recruiting
Newport Huntington Medical Group ( Site 0005)
Huntington Beach, California, United States
Recruiting
Cohen Medical Centers ( Site 0034)
Thousand Oaks, California, United States
Recruiting
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
Upland, California, United States
Recruiting
Arthritis and Rheumatic Disease Specialties ( Site 0016)
Aventura, Florida, United States
Recruiting
Bay Area Arthritis and Osteoporosis ( Site 0041)
Brandon, Florida, United States
Recruiting
GNP Research - Hollywood ( Site 0020)
Cooper City, Florida, United States
Recruiting
Innovation Medical Research Center ( Site 0012)
Palmetto Bay, Florida, United States
Recruiting
Chicago Arthritis & Regenerative Medicine ( Site 0042)
Chicago, Illinois, United States
Recruiting
Willow Rheumatology and Wellness, PLLC ( Site 0035)
Willowbrook, Illinois, United States
Recruiting
John Hopkins University ( Site 0052)
Baltimore, Maryland, United States
Recruiting
Arthritis and Rheumatism Associates - Rockville ( Site 0019)
Rockville, Maryland, United States
Recruiting
Kansas City Physician Partners ( Site 0027)
Kansas City, Missouri, United States
Recruiting
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)
St Louis, Missouri, United States
Recruiting
Logan Health Rheumatology ( Site 0015)
Kalispell, Montana, United States
Recruiting
Physician Research Collaboration, LLC ( Site 0057)
Lincoln, Nebraska, United States
Recruiting
Inspire Santa Fe Medical Group ( Site 0011)
Santa Fe, New Mexico, United States
Recruiting
Oregon Health & Science University ( Site 0059)
Portland, Oregon, United States
Recruiting
Altoona Center for Clinical Research ( Site 0004)
Duncansville, Pennsylvania, United States
Recruiting
Perelman Center for Advanced Medicine ( Site 0060)
Philadelphia, Pennsylvania, United States
Recruiting
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)
Murfreesboro, Tennessee, United States
Recruiting
Rheumatology Associates ( Site 0055)
Arlington, Texas, United States
Recruiting
Arthritis Care of Texas ( Site 0048)
Corpus Christi, Texas, United States
Recruiting
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)
Fort Worth, Texas, United States
Recruiting
Provecta Research Network LLC ( Site 0054)
Houston, Texas, United States
Recruiting
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)
Irving, Texas, United States
Recruiting
Epic Medical Research ( Site 0061)
Red Oak, Texas, United States
Recruiting
Advanced Rheumatology of Houston ( Site 0001)
The Woodlands, Texas, United States
Recruiting
DM Clinical Research - TRA ( Site 0010)
Tomball, Texas, United States
Recruiting
CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)
Juiz de Fora, Minas Gerais, Brazil
Recruiting
Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)
Curitiba, Paraná, Brazil
Recruiting
LMK Serviços Médicos S/S ( Site 2000)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)
Rio de Janeiro, Brazil
Recruiting
Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)
São Paulo, Brazil
Recruiting
Toronto Western Hospital ( Site 0205)
Toronto, Ontario, Canada
Recruiting
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)
Québec, Quebec, Canada
Recruiting
Centre de Recherche Musculo-Squelettique ( Site 0202)
Trois-Rivières, Quebec, Canada
Recruiting
Bioreuma ( Site 2109)
Concepción, Biobio, Chile
Recruiting
Clinica Alemana Osorno ( Site 2114)
Osorno, Los Lagos Region, Chile
Recruiting
Centro de Estudios GyC ( Site 2103)
Santiago, Region M. de Santiago, Chile
Active, not recruiting
Enroll SpA ( Site 2101)
Santiago, Region M. de Santiago, Chile
Active, not recruiting
Bradfordhill ( Site 2110)
Santiago, Region M. de Santiago, Chile
Active, not recruiting
The First Afflilated Hospital of Bengbu Medical College ( Site 3119)
Bengbu, Anhui, China
Recruiting
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)
Beijing, Beijing Municipality, China
Recruiting
Guangdong Provincial People's Hospital ( Site 3110)
Guangzhou, Guangdong, China
Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)
Guangzhou, Guangdong, China
Recruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)
Luoyang, Henan, China
Recruiting
Pingxiang People's Hospital ( Site 3115)
Pingxiang, Jiangxi, China
Recruiting
The First Hospital Of Jilin University ( Site 3103)
Changchun, Jilin, China
Recruiting
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)
Ürümqi, Xinjiang, China
Recruiting
First Affiliated Hospital of Kunming Medical University ( Site 3123)
Kunming, Yunnan, China
Recruiting
Clinica de la Costa S.A.S. ( Site 2202)
Barranquilla, Atlántico, Colombia
Recruiting
CIREEM SAS ( Site 2204)
Bogota, Cundinamarca, Colombia
Active, not recruiting
Fundación Valle del Lili ( Site 2201)
Cali, Valle del Cauca Department, Colombia
Recruiting
Showing 60 of 105 sites — filter to narrow it down. 97 of the 105 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07133633. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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