A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
Start Date
9/26/2025
Completion Date
2/5/2030
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
Tulisokibart
Placebo
Conditions
Locations
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Chandler, Arizona 85225
United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
Flagstaff, Arizona 86001
United States
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
Gilbert, Arizona 85297
United States
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
Glendale, Arizona 85306
United States
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
Tucson, Arizona 85704-1140
United States
TriWest Research Associates - Chula Vista ( Site 0013)
Chula Vista, California 91910
United States
Providence Medical Foundation ( Site 0049)
Fullerton, California 92835
United States
Newport Huntington Medical Group ( Site 0005)
Huntington Beach, California 92648
United States
Cohen Medical Centers ( Site 0034)
Thousand Oaks, California 91360-3967
United States
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
Upland, California 91786
United States
Arthritis and Rheumatic Disease Specialties ( Site 0016)
Aventura, Florida 33180
United States
Bay Area Arthritis and Osteoporosis ( Site 0041)
Brandon, Florida 33511
United States
GNP Research - Hollywood ( Site 0020)
Cooper City, Florida 33024
United States
Innovation Medical Research Center ( Site 0012)
Palmetto Bay, Florida 33157
United States
Chicago Arthritis & Regenerative Medicine ( Site 0042)
Chicago, Illinois 60661
United States
Willow Rheumatology and Wellness, PLLC ( Site 0035)
Willowbrook, Illinois 60527
United States
John Hopkins University ( Site 0052)
Baltimore, Maryland 21224
United States
Arthritis and Rheumatism Associates - Rockville ( Site 0019)
Rockville, Maryland 20850
United States
Kansas City Physician Partners ( Site 0027)
Kansas City, Missouri 64111
United States
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)
St Louis, Missouri 63131
United States
Logan Health Rheumatology ( Site 0015)
Kalispell, Montana 59901
United States
Physician Research Collaboration, LLC ( Site 0057)
Lincoln, Nebraska 68516-5497
United States
Inspire Santa Fe Medical Group ( Site 0011)
Santa Fe, New Mexico 87505
United States
Oregon Health & Science University ( Site 0059)
Portland, Oregon 97239
United States
Altoona Center for Clinical Research ( Site 0004)
Duncansville, Pennsylvania 16635
United States
Perelman Center for Advanced Medicine ( Site 0060)
Philadelphia, Pennsylvania 19104
United States
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)
Murfreesboro, Tennessee 37128
United States
Rheumatology Associates ( Site 0055)
Arlington, Texas 76012
United States
Arthritis Care of Texas ( Site 0048)
Corpus Christi, Texas 78415
United States
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)
Fort Worth, Texas 76109
United States
Provecta Research Network LLC ( Site 0054)
Houston, Texas 77027
United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)
Irving, Texas 75039
United States
Epic Medical Research ( Site 0061)
Red Oak, Texas 75154
United States
Advanced Rheumatology of Houston ( Site 0001)
The Woodlands, Texas 77382
United States
DM Clinical Research - TRA ( Site 0010)
Tomball, Texas 77375
United States
CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)
Juiz de Fora, Minas Gerais 36010-570
Brazil
Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)
Curitiba, Paraná 80060-900
Brazil
LMK Serviços Médicos S/S ( Site 2000)
Porto Alegre, Rio Grande do Sul 90480-000
Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)
Rio de Janeiro, 20241-180
Brazil
Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)
São Paulo, 05403-000
Brazil
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)
Québec, Quebec G1V 4K5
Canada
Centre de Recherche Musculo-Squelettique ( Site 0202)
Trois-Rivières, Quebec G9A 3Y2
Canada
Bioreuma ( Site 2109)
Concepción, Biobio 4070280
Chile
Clinica Alemana Osorno ( Site 2114)
Osorno, Los Lagos Region 5311089
Chile
Centro de Estudios GyC ( Site 2103)
Santiago, Region M. de Santiago 7500504
Chile
Enroll SpA ( Site 2101)
Santiago, Region M. de Santiago 7500587
Chile
Bradfordhill ( Site 2110)
Santiago, Region M. de Santiago 8420383
Chile
The First Afflilated Hospital of Bengbu Medical College ( Site 3119)
Bengbu, Anhui 233004
China
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)
Beijing, Beijing Municipality 100005
China
Guangdong Provincial People's Hospital ( Site 3110)
Guangzhou, Guangdong 510080
China
The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)
Guangzhou, Guangdong 510630
China
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)
Luoyang, Henan 471003
China
Pingxiang People's Hospital ( Site 3115)
Pingxiang, Jiangxi 337055
China
The First Hospital Of Jilin University ( Site 3103)
Changchun, Jilin 130021
China
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)
Ürümqi, Xinjiang 830001
China
First Affiliated Hospital of Kunming Medical University ( Site 3123)
Kunming, Yunnan 650032
China
Clinica de la Costa S.A.S. ( Site 2202)
Barranquilla, Atlántico 080020
Colombia
CIREEM SAS ( Site 2204)
Bogota, Cundinamarca 110221
Colombia
Fundación Valle del Lili ( Site 2201)
Cali, Valle del Cauca Department 760032
Colombia
Medicover München Ost MVZ ( Site 0611)
Munich, Bavaria 81667
Germany
Rheuma-Research Lausitz ( Site 0609)
Cottbus, Brandenburg 03042
Germany
Rheumazentrum Ruhrgebiet ( Site 0600)
Herne, North Rhine-Westphalia 44649
Germany
Rheumazentrum Ratingen Studienambulanz ( Site 0602)
Ratingen, North Rhine-Westphalia 40878
Germany
Rheumatologische Schwerpunktpraxis ( Site 0605)
Berlin, 10777
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)
Berlin, 12203
Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)
Hamburg, 20095
Germany
Zuyderland Medical Centre ( Site 1100)
Heerlen, Limburg 6419 PC
Netherlands
Amsterdam UMC ( Site 1101)
Amsterdam, North Holland 1081 HV
Netherlands
Maasstad Ziekenhuis ( Site 1102)
Rotterdam, South Holland 3079DZ
Netherlands
MICS Centrum Medyczne Bydgoszcz ( Site 1206)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065
Poland
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168
Poland
MICS Centrum Medyczne Torun ( Site 1202)
Torun, Kuyavian-Pomeranian Voivodeship 87-100
Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)
Lublin, Lublin Voivodeship 20-607
Poland
MICS Centrum Medyczne Warszawa ( Site 1204)
Warsaw, Masovian Voivodeship 00-874
Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)
Warsaw, Masovian Voivodeship 02-637
Poland
Kyung Hee University Hospital ( Site 2803)
Seoul, 02447
South Korea
Hanyang University Seoul Hospital ( Site 2800)
Seoul, 04763
South Korea
Kyung Hee University Hosptial at Gangdong ( Site 2802)
Seoul, 05278
South Korea
Taipei Medical University Shuang Ho Hospital ( Site 2900)
New Taipei City, New Taipei 235
Taiwan
National Taiwan University Hospital ( Site 2902)
Taipei City, Taipei 100
Taiwan
Kaohsiung Veterans General Hospital ( Site 2905)
Kaohsiung City, 813414
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)
Kaohsiung City, 833
Taiwan
National Cheng Kung University Hospital ( Site 2903)
Tainan, 704
Taiwan
Taipei Veterans General Hospital ( Site 2906)
Taipei, 112
Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)
Taoyuan, 33305
Taiwan
Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)
Fatih, Istanbul 34098
Turkey (Türkiye)
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)
Ankara, 06230
Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1603)
Ankara, 06230
Turkey (Türkiye)
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1602)
Istanbul, 34899
Turkey (Türkiye)
Kocaeli Üniversitesi ( Site 1605)
Kocaeli, 41380
Turkey (Türkiye)
Konya Necmettin Erbakan Universitesi ( Site 1606)
Konya, 42090
Turkey (Türkiye)
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)
Cherkasy, Chernivetska Oblast 18009
Ukraine
Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018
Ukraine
Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)
Khmelnytskiy, Khmelnytskyi Oblast 29000
Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)
Kyiv, Kyivska Oblast 04050
Ukraine
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)
Lviv, Lviv Oblast 79011
Ukraine
ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)
Ternopil, Ternopil Oblast 46002
Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)
Vinnytsa, Vinnytsia Oblast 21018
Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)
Kyiv, 03049
Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)
Kyiv, 03057
Ukraine
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)
Norwich, Norfolk NR4 7UY
United Kingdom
Royal United Hospital Bath NHS Foundation Trust ( Site 1803)
Bath, Somerset BA1 3NG
United Kingdom
Barnet Hospital ( Site 1806)
Barnet, EN5 3DJ
United Kingdom
St Luke's Hospital ( Site 1801)
Bradford, BD5 0NA
United Kingdom