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RECRUITING
NCT07133633
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2025-09-26

Completion Date

2030-02-05

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Tulisokibart

Subcutaneous (SC) administration

DRUG

Placebo

SC administration

Locations (89)

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

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

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

Physician Research Collaboration, LLC ( Site 0057)

Lincoln, Nebraska, United States

Inspire Santa Fe Medical Group ( Site 0011)

Santa Fe, New Mexico, 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

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

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

Clinica Alemana Osorno ( Site 2114)

Osorno, Los Lagos Region, Chile

Centro de Estudios GyC ( Site 2103)

Santiago, Region M. de Santiago, Chile

Enroll SpA ( Site 2101)

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

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

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 District, Taiwan

Hacettepe Universite Hastaneleri ( Site 1603)

Ankara, 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)

Ukraine, 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