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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07133633

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Tulisokibart (Drug)
    Subcutaneous (SC) administration
  • Placebo (Drug)
    SC administration

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

Conditions

Radiographic Axial Spondyloarthritis

Locations

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036) — Chandler, Arizona, United States
  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021) — Flagstaff, Arizona, United States
  • Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022) — Gilbert, Arizona, United States
  • AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056) — Glendale, Arizona, United States
  • Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025) — Tucson, Arizona, United States
  • TriWest Research Associates - Chula Vista ( Site 0013) — Chula Vista, California, United States
  • Providence Medical Foundation ( Site 0049) — Fullerton, California, United States
  • Newport Huntington Medical Group ( Site 0005) — Huntington Beach, California, United States
  • Cohen Medical Centers ( Site 0034) — Thousand Oaks, California, United States
  • Inland Rheumatology Clinical Trials, Inc. ( Site 0002) — Upland, California, United States
  • Denver Arthritis Clinic ( Site 0064) — Denver, Colorado, United States
  • Arthritis and Rheumatic Disease Specialties ( Site 0016) — Aventura, Florida, United States
  • Bay Area Arthritis and Osteoporosis ( Site 0041) — Brandon, Florida, United States
  • GNP Research - Hollywood ( Site 0020) — Cooper City, Florida, United States
  • Innovation Medical Research Center ( Site 0012) — Palmetto Bay, Florida, United States
  • Chicago Arthritis & Regenerative Medicine ( Site 0042) — Chicago, Illinois, United States
  • Willow Rheumatology and Wellness, PLLC ( Site 0035) — Willowbrook, Illinois, United States
  • John Hopkins University ( Site 0052) — Baltimore, Maryland, United States
  • Arthritis and Rheumatism Associates - Rockville ( Site 0019) — Rockville, Maryland, United States
  • Kansas City Physician Partners ( Site 0027) — Kansas City, Missouri, United States
  • Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038) — St Louis, Missouri, United States
  • Logan Health Rheumatology ( Site 0015) — Kalispell, Montana, United States
  • Physician Research Collaboration, LLC ( Site 0057) — Lincoln, Nebraska, United States
  • Inspire Santa Fe Medical Group ( Site 0011) — Santa Fe, New Mexico, United States
  • Oregon Health & Science University ( Site 0059) — Portland, Oregon, United States
  • Altoona Center for Clinical Research ( Site 0004) — Duncansville, Pennsylvania, United States
  • Perelman Center for Advanced Medicine ( Site 0060) — Philadelphia, Pennsylvania, United States
  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029) — Murfreesboro, Tennessee, United States
  • Rheumatology Associates ( Site 0055) — Arlington, Texas, United States
  • Arthritis Care of Texas ( Site 0048) — Corpus Christi, Texas, United States
  • Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028) — Fort Worth, Texas, United States
  • Provecta Research Network LLC ( Site 0054) — Houston, Texas, United States
  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032) — Irving, Texas, United States
  • Epic Medical Research ( Site 0061) — Red Oak, Texas, United States
  • Advanced Rheumatology of Houston ( Site 0001) — The Woodlands, Texas, United States
  • DM Clinical Research - TRA ( Site 0010) — Tomball, Texas, United States
  • CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999) — Juiz de Fora, Minas Gerais, Brazil
  • Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991) — Curitiba, Paraná, Brazil
  • LMK Serviços Médicos S/S ( Site 2000) — Porto Alegre, Rio Grande do Sul, Brazil
  • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994) — Rio de Janeiro, Brazil
  • Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992) — São Paulo, Brazil
  • Toronto Western Hospital ( Site 0205) — Toronto, Ontario, Canada
  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200) — Québec, Quebec, Canada
  • Centre de Recherche Musculo-Squelettique ( Site 0202) — Trois-Rivières, Quebec, Canada
  • Bioreuma ( Site 2109) — Concepción, Biobio, Chile
  • Clinica Alemana Osorno ( Site 2114) — Osorno, Los Lagos Region, Chile
  • Enroll SpA ( Site 2101) — Santiago, Region M. de Santiago, Chile
  • Centro de Estudios GyC ( Site 2103) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 2110) — Santiago, Region M. de Santiago, Chile
  • The First Afflilated Hospital of Bengbu Medical College ( Site 3119) — Bengbu, Anhui, China
  • Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100) — Beijing, Beijing Municipality, China
  • Guangdong Provincial People's Hospital ( Site 3110) — Guangzhou, Guangdong, China
  • The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114) — Guangzhou, Guangdong, China
  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121) — Luoyang, Henan, China
  • Pingxiang People's Hospital ( Site 3115) — Pingxiang, Jiangxi, China
  • The First Hospital Of Jilin University ( Site 3103) — Changchun, Jilin, China
  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124) — Ürümqi, Xinjiang, China
  • First Affiliated Hospital of Kunming Medical University ( Site 3123) — Kunming, Yunnan, China
  • Clinica de la Costa S.A.S. ( Site 2202) — Barranquilla, Atlántico, Colombia
  • CIREEM SAS ( Site 2204) — Bogota, Cundinamarca, Colombia
  • Fundación Valle del Lili ( Site 2201) — Cali, Valle del Cauca Department, Colombia
  • Medicover München Ost MVZ ( Site 0611) — Munich, Bavaria, Germany
  • Rheuma-Research Lausitz ( Site 0609) — Cottbus, Brandenburg, Germany
  • Rheumazentrum Ruhrgebiet ( Site 0600) — Herne, North Rhine-Westphalia, Germany
  • Rheumazentrum Ratingen Studienambulanz ( Site 0602) — Ratingen, North Rhine-Westphalia, Germany
  • Rheumatologische Schwerpunktpraxis ( Site 0605) — Berlin, Germany
  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601) — Berlin, Germany
  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604) — Hamburg, Germany
  • Zuyderland Medical Centre ( Site 1100) — Heerlen, Limburg, Netherlands
  • Amsterdam UMC ( Site 1101) — Amsterdam, North Holland, Netherlands
  • Maasstad Ziekenhuis ( Site 1102) — Rotterdam, South Holland, Netherlands
  • MICS Centrum Medyczne Bydgoszcz ( Site 1206) — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203) — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • MICS Centrum Medyczne Torun ( Site 1202) — Torun, Kuyavian-Pomeranian Voivodeship, Poland
  • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201) — Lublin, Lublin Voivodeship, Poland
  • MICS Centrum Medyczne Warszawa ( Site 1204) — Warsaw, Masovian Voivodeship, Poland
  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205) — Warsaw, Masovian Voivodeship, Poland
  • Kyung Hee University Hospital ( Site 2803) — Seoul, South Korea
  • Hanyang University Seoul Hospital ( Site 2800) — Seoul, South Korea
  • Kyung Hee University Hosptial at Gangdong ( Site 2802) — Seoul, South Korea
  • Taipei Medical University Shuang Ho Hospital ( Site 2900) — New Taipei City, New Taipei, Taiwan
  • National Taiwan University Hospital ( Site 2902) — Taipei City, Taipei, Taiwan
  • Kaohsiung Veterans General Hospital ( Site 2905) — Kaohsiung City, Taiwan
  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2908) — Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital ( Site 2903) — Tainan, Taiwan
  • Taipei Veterans General Hospital ( Site 2906) — Taipei, Taiwan
  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2904) — Taoyuan, Taiwan
  • Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604) — Fatih, Istanbul, Turkey (Türkiye)
  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600) — Ankara, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri ( Site 1603) — Ankara, Turkey (Türkiye)
  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1602) — Istanbul, Turkey (Türkiye)
  • Kocaeli Üniversitesi ( Site 1605) — Kocaeli, Turkey (Türkiye)
  • Konya Necmettin Erbakan Universitesi ( Site 1606) — Konya, Turkey (Türkiye)
  • Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704) — Cherkasy, Chernivetska Oblast, Ukraine
  • Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
  • Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713) — Khmelnytskiy, Khmelnytskyi Oblast, Ukraine
  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715) — Kyiv, Kyivska Oblast, Ukraine
  • Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710) — Lviv, Lviv Oblast, Ukraine
  • ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707) — Ternopil, Ternopil Oblast, Ukraine
  • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700) — Vinnytsa, Vinnytsia Oblast, Ukraine
  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701) — Kyiv, Ukraine
  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706) — Kyiv, Ukraine
  • Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800) — Norwich, Norfolk, United Kingdom
  • Royal United Hospital Bath NHS Foundation Trust ( Site 1803) — Bath, Somerset, United Kingdom
  • Barnet Hospital ( Site 1806) — Barnet, United Kingdom
  • St Luke's Hospital ( Site 1801) — Bradford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record