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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
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

Full criteria on ClinicalTrials.gov

Sites (107)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)
Coordinator of this site? Confirm its status
CuritibaBrazilRecruiting
CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)
Coordinator of this site? Confirm its status
Juiz de ForaBrazilRecruiting
LMK Serviços Médicos S/S ( Site 2000)
Coordinator of this site? Confirm its status
Porto AlegreBrazilRecruiting
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
Toronto Western Hospital ( Site 0205)
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TorontoCanadaRecruiting
Centre de Recherche Musculo-Squelettique ( Site 0202)
Coordinator of this site? Confirm its status
Trois-RivièresCanadaRecruiting
Bioreuma ( Site 2109)
Coordinator of this site? Confirm its status
ConcepciónChileRecruiting
Clinica Alemana Osorno ( Site 2114)
Coordinator of this site? Confirm its status
OsornoChileRecruiting
Enroll SpA ( Site 2101)
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SantiagoChileActive, not recruiting
Bradfordhill ( Site 2110)
Coordinator of this site? Confirm its status
SantiagoChileActive, not recruiting
Centro de Estudios GyC ( Site 2103)
Coordinator of this site? Confirm its status
SantiagoChileActive, not recruiting
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
The First Afflilated Hospital of Bengbu Medical College ( Site 3119)
Coordinator of this site? Confirm its status
BengbuChinaRecruiting
The First Hospital Of Jilin University ( Site 3103)
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ChangchunChinaRecruiting
The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)
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GuangzhouChinaRecruiting
Guangdong Provincial People's Hospital ( Site 3110)
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GuangzhouChinaRecruiting
First Affiliated Hospital of Kunming Medical University ( Site 3123)
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KunmingChinaRecruiting
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)
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LuoyangChinaRecruiting
Pingxiang People's Hospital ( Site 3115)
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PingxiangChinaRecruiting
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)
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ÜrümqiChinaRecruiting
Clinica de la Costa S.A.S. ( Site 2202)
Coordinator of this site? Confirm its status
BarranquillaColombiaRecruiting
CIREEM SAS ( Site 2204)
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BogotaColombiaActive, not recruiting
Fundación Valle del Lili ( Site 2201)
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CaliColombiaRecruiting
Rheumatologische Schwerpunktpraxis
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BerlinGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Rheuma-Research Lausitz Zentrum für klinische Studien
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CottbusGermanyRecruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
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HamburgGermanyRecruiting
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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HerneGermanyRecruiting
Medicover GmbH
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MunichGermanyRecruiting
Studienambulanz Rheumazentrum Ratingen GbR
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RatingenGermanyRecruiting
Barnet Hospital ( Site 1806)
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BarnetUnited KingdomRecruiting
Royal United Hospital Bath NHS Foundation Trust ( Site 1803)
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BathUnited KingdomRecruiting
St Luke's Hospital ( Site 1801)
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BradfordUnited KingdomRecruiting
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)
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NorwichUnited KingdomRecruiting
Kyung Hee University Hospital ( Site 2803)
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SeoulSouth KoreaRecruiting
Hanyang University Seoul Hospital ( Site 2800)
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SeoulSouth KoreaRecruiting
Kyung Hee University Hosptial at Gangdong ( Site 2802)
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SeoulSouth KoreaRecruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsRecruiting
Zuyderland Medisch Centrum Stichting
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HeerlenNetherlandsRecruiting
Maasstad Ziekenhuis Stichting
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RotterdamNetherlandsRecruiting
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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BydgoszczPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
BydgoszczPolandRecruiting
Reumed Sp. z o.o.
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LublinPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandRecruiting
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Coordinator of this site? Confirm its status
WarsawPolandRecruiting
Medicover Integrated Clinical Services Sp. z o.o.
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WarsawPolandRecruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)
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Kaohsiung CityTaiwanRecruiting
Kaohsiung Veterans General Hospital ( Site 2905)
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Kaohsiung CityTaiwanRecruiting
Taipei Medical University Shuang Ho Hospital ( Site 2900)
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New Taipei CityTaiwanRecruiting
National Cheng Kung University Hospital ( Site 2903)
Coordinator of this site? Confirm its status
TainanTaiwanRecruiting
Taipei Veterans General Hospital ( Site 2906)
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TaipeiTaiwanRecruiting
National Taiwan University Hospital ( Site 2902)
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Taipei CityTaiwanRecruiting
Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)
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TaoyuanTaiwanRecruiting
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)
Coordinator of this site? Confirm its status
CherkasyUkraineActive, 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-FrankivskUkraineActive, not recruiting
Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)
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KhmelnytskiyUkraineRecruiting
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)
Coordinator of this site? Confirm its status
KyivUkraineActive, 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
KyivUkraineRecruiting
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)
Coordinator of this site? Confirm its status
KyivUkraineRecruiting
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)
Coordinator of this site? Confirm its status
LvivUkraineActive, not recruiting
ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)
Coordinator of this site? Confirm its status
TernopilUkraineActive, 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
VinnytsaUkraineActive, not recruiting
Rheumatology Associates ( Site 0055)
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
Arthritis and Rheumatic Disease Specialties ( Site 0016)
Coordinator of this site? Confirm its status
AventuraUnited StatesRecruiting
John Hopkins University ( Site 0052)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Bay Area Arthritis and Osteoporosis ( Site 0041)
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BrandonUnited StatesRecruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Coordinator of this site? Confirm its status
ChandlerUnited StatesRecruiting
Chicago Arthritis & Regenerative Medicine ( Site 0042)
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
TriWest Research Associates - Chula Vista ( Site 0013)
Coordinator of this site? Confirm its status
Chula VistaUnited StatesCompleted
GNP Research - Hollywood ( Site 0020)
Coordinator of this site? Confirm its status
Cooper CityUnited StatesRecruiting
Arthritis Care of Texas ( Site 0048)
Coordinator of this site? Confirm its status
Corpus ChristiUnited StatesRecruiting
Denver Arthritis Clinic ( Site 0064)
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Altoona Center for Clinical Research ( Site 0004)
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DuncansvilleUnited StatesRecruiting
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
Coordinator of this site? Confirm its status
FlagstaffUnited StatesRecruiting
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)
Coordinator of this site? Confirm its status
Fort WorthUnited StatesRecruiting
Providence Medical Foundation ( Site 0049)
Coordinator of this site? Confirm its status
FullertonUnited StatesRecruiting
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
Coordinator of this site? Confirm its status
GilbertUnited StatesRecruiting
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
Coordinator of this site? Confirm its status
GlendaleUnited StatesRecruiting
Provecta Research Network LLC ( Site 0054)
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
The University of Texas Health Science Center at Houston ( Site 0065)
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HoustonUnited StatesRecruiting
Newport Huntington Medical Group ( Site 0005)
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Huntington BeachUnited StatesRecruiting
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)
Coordinator of this site? Confirm its status
IrvingUnited StatesRecruiting
Logan Health Rheumatology ( Site 0015)
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KalispellUnited StatesRecruiting
Kansas City Physician Partners ( Site 0027)
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting
Physician Research Collaboration, LLC ( Site 0057)
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LincolnUnited StatesRecruiting
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)
Coordinator of this site? Confirm its status
MurfreesboroUnited StatesRecruiting
Innovation Medical Research Center ( Site 0012)
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Palmetto BayUnited StatesRecruiting
Perelman Center for Advanced Medicine ( Site 0060)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
Oregon Health & Science University ( Site 0059)
Coordinator of this site? Confirm its status
PortlandUnited StatesRecruiting
Epic Medical Research ( Site 0061)
Coordinator of this site? Confirm its status
Red OakUnited StatesRecruiting
Arthritis and Rheumatism Associates - Rockville ( Site 0019)
Coordinator of this site? Confirm its status
RockvilleUnited StatesRecruiting
Inspire Santa Fe Medical Group ( Site 0011)
Coordinator of this site? Confirm its status
Santa FeUnited StatesRecruiting
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting
Advanced Rheumatology of Houston ( Site 0001)
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The WoodlandsUnited StatesRecruiting
Cohen Medical Centers ( Site 0034)
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Thousand OaksUnited StatesRecruiting
DM Clinical Research - TRA ( Site 0010)
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TomballUnited StatesRecruiting
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
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TucsonUnited StatesRecruiting
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
Coordinator of this site? Confirm its status
UplandUnited StatesRecruiting
Willow Rheumatology and Wellness, PLLC ( Site 0035)
Coordinator of this site? Confirm its status
WillowbrookUnited StatesRecruiting
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Hacettepe Universite Hastaneleri ( Site 1603)
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AnkaraTurkey (Türkiye)Recruiting
Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)
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FatihTurkey (Türkiye)Recruiting
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1602)
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IstanbulTurkey (Türkiye)Recruiting
Kocaeli Üniversitesi ( Site 1605)
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KocaeliTurkey (Türkiye)Recruiting
Konya Necmettin Erbakan Universitesi ( Site 1606)
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KonyaTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.