NCT07133633RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 315 (estimated)
- First submitted
- 14 Aug 2025
- Start date
- 26 Sept 2025
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07133633
- EU CT number
- 2025-521059-21-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 315
- From 26 Sept 2025 to the primary completion date, 15 Jun 2027
- 107 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- 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
Other
- The main exclusion criteria include but are not limited to the following:
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (107)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991) Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999) Coordinator of this site? Confirm its status | Juiz de Fora | Brazil | Recruiting |
| LMK Serviços Médicos S/S ( Site 2000) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200) Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Toronto Western Hospital ( Site 0205) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Centre de Recherche Musculo-Squelettique ( Site 0202) Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Recruiting |
| Bioreuma ( Site 2109) Coordinator of this site? Confirm its status | Concepción | Chile | Recruiting |
| Clinica Alemana Osorno ( Site 2114) Coordinator of this site? Confirm its status | Osorno | Chile | Recruiting |
| Enroll SpA ( Site 2101) Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Bradfordhill ( Site 2110) Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Centro de Estudios GyC ( Site 2103) Coordinator of this site? Confirm its status | Santiago | Chile | Active, not recruiting |
| Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Afflilated Hospital of Bengbu Medical College ( Site 3119) Coordinator of this site? Confirm its status | Bengbu | China | Recruiting |
| The First Hospital Of Jilin University ( Site 3103) Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114) Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial People's Hospital ( Site 3110) Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| First Affiliated Hospital of Kunming Medical University ( Site 3123) Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121) Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Pingxiang People's Hospital ( Site 3115) Coordinator of this site? Confirm its status | Pingxiang | China | Recruiting |
| PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124) Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Clinica de la Costa S.A.S. ( Site 2202) Coordinator of this site? Confirm its status | Barranquilla | Colombia | Recruiting |
| CIREEM SAS ( Site 2204) Coordinator of this site? Confirm its status | Bogota | Colombia | Active, not recruiting |
| Fundación Valle del Lili ( Site 2201) Coordinator of this site? Confirm its status | Cali | Colombia | Recruiting |
| Rheumatologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Rheuma-Research Lausitz Zentrum für klinische Studien Coordinator of this site? Confirm its status | Cottbus | Germany | Recruiting |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Medicover GmbH Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Studienambulanz Rheumazentrum Ratingen GbR Coordinator of this site? Confirm its status | Ratingen | Germany | Recruiting |
| Barnet Hospital ( Site 1806) Coordinator of this site? Confirm its status | Barnet | United Kingdom | Recruiting |
| Royal United Hospital Bath NHS Foundation Trust ( Site 1803) Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| St Luke's Hospital ( Site 1801) Coordinator of this site? Confirm its status | Bradford | United Kingdom | Recruiting |
| Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800) Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| Kyung Hee University Hospital ( Site 2803) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Hanyang University Seoul Hospital ( Site 2800) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kyung Hee University Hosptial at Gangdong ( Site 2802) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Heerlen | Netherlands | Recruiting |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Recruiting |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 2908) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Kaohsiung Veterans General Hospital ( Site 2905) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Taipei Medical University Shuang Ho Hospital ( Site 2900) Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| National Cheng Kung University Hospital ( Site 2903) Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Veterans General Hospital ( Site 2906) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital ( Site 2902) Coordinator of this site? Confirm its status | Taipei City | Taiwan | Recruiting |
| Chang Gung Memorial Hospital - Linkou Branch ( Site 2904) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704) Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Active, not recruiting |
| Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705) Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Active, not recruiting |
| Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713) Coordinator of this site? Confirm its status | Khmelnytskiy | Ukraine | Recruiting |
| Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Active, not recruiting |
| Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715) Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710) Coordinator of this site? Confirm its status | Lviv | Ukraine | Active, not recruiting |
| ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707) Coordinator of this site? Confirm its status | Ternopil | Ukraine | Active, not recruiting |
| Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700) Coordinator of this site? Confirm its status | Vinnytsa | Ukraine | Active, not recruiting |
| Rheumatology Associates ( Site 0055) Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Arthritis and Rheumatic Disease Specialties ( Site 0016) Coordinator of this site? Confirm its status | Aventura | United States | Recruiting |
| John Hopkins University ( Site 0052) Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Bay Area Arthritis and Osteoporosis ( Site 0041) Coordinator of this site? Confirm its status | Brandon | United States | Recruiting |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036) Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| Chicago Arthritis & Regenerative Medicine ( Site 0042) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| TriWest Research Associates - Chula Vista ( Site 0013) Coordinator of this site? Confirm its status | Chula Vista | United States | Completed |
| GNP Research - Hollywood ( Site 0020) Coordinator of this site? Confirm its status | Cooper City | United States | Recruiting |
| Arthritis Care of Texas ( Site 0048) Coordinator of this site? Confirm its status | Corpus Christi | United States | Recruiting |
| Denver Arthritis Clinic ( Site 0064) Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Altoona Center for Clinical Research ( Site 0004) Coordinator of this site? Confirm its status | Duncansville | United States | Recruiting |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021) Coordinator of this site? Confirm its status | Flagstaff | United States | Recruiting |
| Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028) Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Providence Medical Foundation ( Site 0049) Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
| Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022) Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056) Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Provecta Research Network LLC ( Site 0054) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| The University of Texas Health Science Center at Houston ( Site 0065) Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Newport Huntington Medical Group ( Site 0005) Coordinator of this site? Confirm its status | Huntington Beach | United States | Recruiting |
| AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032) Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| Logan Health Rheumatology ( Site 0015) Coordinator of this site? Confirm its status | Kalispell | United States | Recruiting |
| Kansas City Physician Partners ( Site 0027) Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Physician Research Collaboration, LLC ( Site 0057) Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029) Coordinator of this site? Confirm its status | Murfreesboro | United States | Recruiting |
| Innovation Medical Research Center ( Site 0012) Coordinator of this site? Confirm its status | Palmetto Bay | United States | Recruiting |
| Perelman Center for Advanced Medicine ( Site 0060) Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Oregon Health & Science University ( Site 0059) Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Epic Medical Research ( Site 0061) Coordinator of this site? Confirm its status | Red Oak | United States | Recruiting |
| Arthritis and Rheumatism Associates - Rockville ( Site 0019) Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
| Inspire Santa Fe Medical Group ( Site 0011) Coordinator of this site? Confirm its status | Santa Fe | United States | Recruiting |
| Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038) Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Advanced Rheumatology of Houston ( Site 0001) Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Cohen Medical Centers ( Site 0034) Coordinator of this site? Confirm its status | Thousand Oaks | United States | Recruiting |
| DM Clinical Research - TRA ( Site 0010) Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025) Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Inland Rheumatology Clinical Trials, Inc. ( Site 0002) Coordinator of this site? Confirm its status | Upland | United States | Recruiting |
| Willow Rheumatology and Wellness, PLLC ( Site 0035) Coordinator of this site? Confirm its status | Willowbrook | United States | Recruiting |
| ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Hacettepe Universite Hastaneleri ( Site 1603) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604) Coordinator of this site? Confirm its status | Fatih | Turkey (Türkiye) | Recruiting |
| Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1602) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Kocaeli Üniversitesi ( Site 1605) Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Recruiting |
| Konya Necmettin Erbakan Universitesi ( Site 1606) Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.