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NCT07133633PHASE2Recruiting

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

Merck Sharp & Dohme LLC

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

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

Interventions

DRUG

Tulisokibart

DRUG

Placebo

Interested in This Trial?

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Conditions

Radiographic Axial Spondyloarthritis

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