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

Last updated: June 11, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Ankylosing Spondylitis

Treatment

Placebo

Tulisokibart

Clinical Study ID

NCT07133633
7240-013
2025-521059-21-00
U1111-1318-5807
MK-7240-013
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Assessmentof SpondyloArthritis international Society (ASAS) classification criteria for axSpAincluding ≥3 months of back pain with age at symptom onset <45 years

  • Meets the radiographic criterion of the modified New York criteria for ankylosingspondylitis (AS) as determined by central reading at Screening

  • Has active disease at Screening and Randomization

  • Has a history of inadequate response (IR)/intolerance to nonsteroidalanti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumaticdrug (bDMARD)-naive, or has a history of IR/intolerance to up to a maximum of 2bDMARD classes

Exclusion

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 ofinflammatory 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 otherconditions that may, in the judgment of the investigator, interfere with theassessment of r-axSpA

  • Has a history of cancer (except fully treated non-melanoma skin cancers or cervicalcarcinoma in situ after complete surgical removal) within the last 5 years

  • Has any active infection

  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or itsexcipients

Study Design

Total Participants: 315
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 26, 2025
Estimated Completion Date:
February 05, 2030

Study Description

This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional Extension.

Connect with a study center

  • CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)

    Juiz de Fora, Minas Gerais 36010-570
    Brazil

    Active - Recruiting

  • Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)

    Curitiba, Paraná 80060-900
    Brazil

    Active - Recruiting

  • LMK Serviços Médicos S/S ( Site 2000)

    Porto Alegre, Rio Grande do Sul 90480-000
    Brazil

    Active - Recruiting

  • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)

    Rio de Janeiro, 20241-180
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)

    São Paulo, 05403-000
    Brazil

    Active - Recruiting

  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)

    Québec, Quebec G1V 3M7
    Canada

    Active - Recruiting

  • Centre de Recherche Musculo-Squelettique ( Site 0202)

    Trois-Rivières, Quebec G9A 3Y2
    Canada

    Active - Recruiting

  • Bioreuma ( Site 2109)

    Concepción, Biobio 4070280
    Chile

    Active - Recruiting

  • Clinica Alemana Osorno ( Site 2114)

    Osorno, Los Lagos Region 5311089
    Chile

    Active - Recruiting

  • Bradfordhill ( Site 2110)

    Santiago, Region M. de Santiago 8420383
    Chile

    Active - Recruiting

  • Centro de Estudios GyC ( Site 2103)

    Santiago, Region M. de Santiago 7500504
    Chile

    Active - Recruiting

  • Enroll SpA ( Site 2101)

    Santiago, Region M. de Santiago 7500587
    Chile

    Active - Recruiting

  • Enroll SpA ( Site 2101)

    Santiago 3871336, Region M. de Santiago 7500587
    Chile

    Active - Recruiting

  • The First Afflilated Hospital of Bengbu Medical College ( Site 3119)

    Bengbu, Anhui 233004
    China

    Active - Recruiting

  • Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)

    Beijing, Beijing Municipality 100005
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital ( Site 3110)

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)

    Guangzhou 1809858, Guangdong 1809935 510630
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)

    Luoyang, Henan 471003
    China

    Active - Recruiting

  • Pingxiang People's Hospital ( Site 3115)

    Pingxiang, Jiangxi 337055
    China

    Active - Recruiting

  • The First Hospital Of Jilin University ( Site 3103)

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)

    Ürümqi, Xinjiang 830001
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University ( Site 3123)

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • Clinica de la Costa S.A.S. ( Site 2202)

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

  • CIREEM SAS ( Site 2204)

    Bogota, Cundinamarca 110221
    Colombia

    Site Not Available

  • Fundación Valle del Lili ( Site 2201)

    Cali, Valle del Cauca Department 760032
    Colombia

    Active - Recruiting

  • Medicover München Ost MVZ ( Site 0611)

    Munich, Bavaria 81667
    Germany

    Active - Recruiting

  • Rheumazentrum Ruhrgebiet ( Site 0600)

    Herne, North Rhine-Westphalia 44649
    Germany

    Active - Recruiting

  • Rheumazentrum Ratingen Studienambulanz ( Site 0602)

    Ratingen, North Rhine-Westphalia 40878
    Germany

    Active - Recruiting

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)

    Berlin, 12203
    Germany

    Active - Recruiting

  • Rheumatologische Schwerpunktpraxis ( Site 0605)

    Berlin, 12161
    Germany

    Active - Recruiting

  • Rheumatologische Schwerpunktpraxis ( Site 0605)

    Berlin 2950159, 12161
    Germany

    Active - Recruiting

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Zuyderland Medical Centre ( Site 1100)

    Heerlen, Limburg 6419 PC
    Netherlands

    Active - Recruiting

  • Amsterdam UMC ( Site 1101)

    Amsterdam, North Holland 1081 HV
    Netherlands

    Active - Recruiting

  • Maasstad Ziekenhuis ( Site 1102)

    Rotterdam, South Holland 3079DZ
    Netherlands

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz ( Site 1206)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Torun ( Site 1202)

    Torun, Kuyavian-Pomeranian Voivodeship 87-100
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz ( Site 1206)

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-065
    Poland

    Active - Recruiting

  • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)

    Lublin, Lublin Voivodeship 20-607
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa ( Site 1204)

    Warsaw, Masovian Voivodeship 00-874
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)

    Warsaw, Masovian Voivodeship 02-637
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)

    Warsaw 756135, Masovian Voivodeship 858787 02-637
    Poland

    Active - Recruiting

  • Hanyang University Seoul Hospital ( Site 2800)

    Seoul, 04763
    South Korea

    Active - Recruiting

  • Kyung Hee University Hospital ( Site 2803)

    Seoul, 02447
    South Korea

    Active - Recruiting

  • Kyung Hee University Hosptial at Gangdong ( Site 2802)

    Seoul, 05278
    South Korea

    Active - Recruiting

  • Kyung Hee University Hosptial at Gangdong ( Site 2802)

    Seoul 1835848, 05278
    South Korea

    Active - Recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 2900)

    New Taipei City, New Taipei 235
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital ( Site 2902)

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital ( Site 2905)

    Kaohsiung City, 813414
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)

    Kaohsiung City 1673820, 833
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital ( Site 2903)

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital Institutional Review Board ( Site 2903)

    Tainan 1668355, 704
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 2906)

    Taipei, 112
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)

    Fatih, Istanbul 34098
    Turkey (Türkiye)

    Active - Recruiting

  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1603)

    Ankara, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Kocaeli Üniversitesi ( Site 1605)

    Kocaeli, 41380
    Turkey (Türkiye)

    Active - Recruiting

  • Konya Necmettin Erbakan Universitesi ( Site 1606)

    Konya, 42090
    Turkey (Türkiye)

    Active - Recruiting

  • Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)

    Cherkasy, Chernivetska Oblast 18009
    Ukraine

    Active - Recruiting

  • Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)

    Ukraine, Ivano-Frankivsk Oblast 76018
    Ukraine

    Active - Recruiting

  • Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)

    Khmelnytskiy, Khmelnytskyi Oblast 29000
    Ukraine

    Active - Recruiting

  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)

    Kyiv, Kyivska Oblast 04050
    Ukraine

    Active - Recruiting

  • Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)

    Lviv, Lviv Oblast 79011
    Ukraine

    Active - Recruiting

  • ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)

    Ternopil, Ternopil Oblast 46002
    Ukraine

    Active - Recruiting

  • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)

    Vinnytsa, Vinnytsia Oblast 21018
    Ukraine

    Active - Recruiting

  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)

    Kyiv, 03049
    Ukraine

    Active - Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)

    Kyiv, 03057
    Ukraine

    Active - Recruiting

  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)

    Kyiv 703448, 03049
    Ukraine

    Active - Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)

    Kyiv 703448, 03057
    Ukraine

    Active - Recruiting

  • Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Active - Recruiting

  • Royal United Hospital Bath NHS Foundation Trust ( Site 1803)

    Bath, Somerset BA1 3NG
    United Kingdom

    Active - Recruiting

  • Barnet Hospital ( Site 1806)

    Barnet, EN5 3DJ
    United Kingdom

    Active - Recruiting

  • St Luke's Hospital ( Site 1801)

    Bradford, BD5 0NA
    United Kingdom

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)

    Tucson, Arizona 85704-1140
    United States

    Active - Recruiting

  • TriWest Research Associates - Chula Vista ( Site 0013)

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Providence Medical Foundation ( Site 0049)

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Newport Huntington Medical Group ( Site 0005)

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Cohen Medical Centers ( Site 0034)

    Thousand Oaks, California 91360-3967
    United States

    Active - Recruiting

  • Inland Rheumatology Clinical Trials, Inc. ( Site 0002)

    Upland, California 91786
    United States

    Active - Recruiting

  • Arthritis and Rheumatic Disease Specialties ( Site 0016)

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • Bay Area Arthritis and Osteoporosis ( Site 0041)

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • GNP Research - Hollywood ( Site 0020)

    Cooper City, Florida 33024
    United States

    Active - Recruiting

  • Innovation Medical Research Center ( Site 0012)

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Chicago Arthritis & Regenerative Medicine ( Site 0042)

    Chicago, Illinois 60661
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness, PLLC ( Site 0035)

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Arthritis and Rheumatism Associates - Rockville ( Site 0019)

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Kansas City Physician Partners ( Site 0027)

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)

    St Louis, Missouri 63131
    United States

    Active - Recruiting

  • Physician Research Collaboration, LLC ( Site 0057)

    Lincoln, Nebraska 68516-5497
    United States

    Active - Recruiting

  • Inspire Santa Fe Medical Group ( Site 0011)

    Santa Fe, New Mexico 87505
    United States

    Active - Recruiting

  • Oregon Health & Science University ( Site 0059)

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Altoona Center for Clinical Research ( Site 0004)

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Perelman Center for Advanced Medicine ( Site 0060)

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)

    Murfreesboro, Tennessee 37128
    United States

    Active - Recruiting

  • Rheumatology Associates ( Site 0055)

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Arthritis Care of Texas ( Site 0048)

    Corpus Christi, Texas 78415
    United States

    Active - Recruiting

  • Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)

    Fort Worth, Texas 76109
    United States

    Active - Recruiting

  • Provecta Research Network LLC ( Site 0054)

    Houston, Texas 77027
    United States

    Active - Recruiting

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)

    Irving, Texas 75039
    United States

    Active - Recruiting

  • Epic Medical Research ( Site 0061)

    Red Oak, Texas 75154
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston ( Site 0001)

    The Woodlands, Texas 77382
    United States

    Active - Recruiting

  • DM Clinical Research - TRA ( Site 0010)

    Tomball, Texas 77375
    United States

    Active - Recruiting

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