Language: BG BG
← Back to results
Recruiting Phase 2 NCT07133633

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

Phase 2 – studying effectiveness and dosage
Conditions: Radiographic Axial Spondyloarthritis

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Tulisokibart
DRUG
Placebo
DRUG
Locations 95
Brazil (5)
Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)
Curitiba , Paraná
Study Coordinator
CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)
Juiz de Fora , Minas Gerais
Study Coordinator
LMK Serviços Médicos S/S ( Site 2000)
Porto Alegre , Rio Grande do Sul
Study Coordinator
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)
Rio de Janeiro
Study Coordinator
Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)
São Paulo
Study Coordinator
Canada (2)
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)
Québec , Quebec
Study Coordinator
Centre de Recherche Musculo-Squelettique ( Site 0202)
Trois-Rivières , Quebec
Study Coordinator
Chile (3)
Clinica Alemana Osorno ( Site 2114)
Osorno , Los Lagos Region
Study Coordinator
Centro de Estudios GyC ( Site 2103)
Santiago , Region M. de Santiago
Study Coordinator
Enroll SpA ( Site 2101)
Santiago , Region M. de Santiago
Study Coordinator
China (9)
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)
Beijing , Beijing Municipality
Study Coordinator
The First Afflilated Hospital of Bengbu Medical College ( Site 3119)
Bengbu , Anhui
Study Coordinator
The First Hospital Of Jilin University ( Site 3103)
Changchun , Jilin
Study Coordinator
Guangdong Provincial People's Hospital ( Site 3110)
Guangzhou , Guangdong
Study Coordinator
The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)
Guangzhou , Guangdong
Study Coordinator
First Affiliated Hospital of Kunming Medical University ( Site 3123)
Kunming , Yunnan
Study Coordinator
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)
Luoyang , Henan
Study Coordinator
Pingxiang People's Hospital ( Site 3115)
Pingxiang , Jiangxi
Study Coordinator
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)
Ürümqi , Xinjiang
Study Coordinator
Colombia (3)
Clinica de la Costa S.A.S. ( Site 2202)
Barranquilla , Atlántico
Study Coordinator
CIREEM SAS ( Site 2204)
Bogota , Cundinamarca
ACTIVE_NOT_RECRUITING
Fundación Valle del Lili ( Site 2201)
Cali , Valle del Cauca Department
Study Coordinator
Germany (6)
Rheumatologische Schwerpunktpraxis ( Site 0605)
Berlin
Study Coordinator
Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)
Berlin
Study Coordinator
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)
Hamburg
Study Coordinator
Rheumazentrum Ruhrgebiet ( Site 0600)
Herne , North Rhine-Westphalia
Study Coordinator
Medicover München Ost MVZ ( Site 0611)
Munich , Bavaria
Study Coordinator
Rheumazentrum Ratingen Studienambulanz ( Site 0602)
Ratingen , North Rhine-Westphalia
Study Coordinator
Netherlands (3)
Amsterdam UMC ( Site 1101)
Amsterdam , North Holland
Study Coordinator
Zuyderland Medical Centre ( Site 1100)
Heerlen , Limburg
Study Coordinator
Maasstad Ziekenhuis ( Site 1102)
Rotterdam , South Holland
Study Coordinator
Poland (6)
MICS Centrum Medyczne Bydgoszcz ( Site 1206)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Study Coordinator
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Study Coordinator
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)
Lublin , Lublin Voivodeship
Study Coordinator
MICS Centrum Medyczne Torun ( Site 1202)
Torun , Kuyavian-Pomeranian Voivodeship
Study Coordinator
MICS Centrum Medyczne Warszawa ( Site 1204)
Warsaw , Masovian Voivodeship
Study Coordinator
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)
Warsaw , Masovian Voivodeship
Study Coordinator
South Korea (2)
Hanyang University Seoul Hospital ( Site 2800)
Seoul
Study Coordinator
Kyung Hee University Hosptial at Gangdong ( Site 2802)
Seoul
Study Coordinator
Taiwan (7)
Kaohsiung Veterans General Hospital ( Site 2905)
Kaohsiung City
Study Coordinator
Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)
Kaohsiung City
Study Coordinator
Taipei Medical University Shuang Ho Hospital ( Site 2900)
New Taipei City , New Taipei
Study Coordinator
National Cheng Kung University Hospital ( Site 2903)
Tainan
Study Coordinator
Taipei Veterans General Hospital ( Site 2906)
Taipei
Study Coordinator
National Taiwan University Hospital ( Site 2902)
Taipei City , Taipei
Study Coordinator
Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)
Taoyuan District
Study Coordinator
Turkey (4)
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)
Ankara
Study Coordinator
Hacettepe Universite Hastaneleri ( Site 1603)
Ankara
Study Coordinator
Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)
Fatih , Istanbul
Study Coordinator
Konya Necmettin Erbakan Universitesi ( Site 1606)
Konya
Study Coordinator
Ukraine (9)
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)
Cherkasy , Chernivetska Oblast
Study Coordinator
Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)
Khmelnytskiy , Khmelnytskyi Oblast
Study Coordinator
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)
Kyiv , Kyivska Oblast
Study Coordinator
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)
Kyiv
Study Coordinator
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)
Kyiv
Study Coordinator
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)
Lviv , Lviv Oblast
Study Coordinator
ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)
Ternopil , Ternopil Oblast
Study Coordinator
Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)
Ukraine , Ivano-Frankivsk Oblast
Study Coordinator
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)
Vinnytsa , Vinnytsia Oblast
Study Coordinator
United Kingdom (4)
Barnet Hospital ( Site 1806)
Barnet
Study Coordinator
Royal United Hospital Bath NHS Foundation Trust ( Site 1803)
Bath , Somerset
Study Coordinator
St Luke's Hospital ( Site 1801)
Bradford
Study Coordinator
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)
Norwich , Norfolk
Study Coordinator
United States (32)
Rheumatology Associates ( Site 0055)
Arlington , Texas
Study Coordinator
Arthritis and Rheumatic Disease Specialties ( Site 0016)
Aventura , Florida
Study Coordinator
Bay Area Arthritis and Osteoporosis ( Site 0041)
Brandon , Florida
Study Coordinator
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
Chandler , Arizona
Study Coordinator
Chicago Arthritis & Regenerative Medicine ( Site 0042)
Chicago , Illinois
Study Coordinator
TriWest Research Associates - Chula Vista ( Site 0013)
Chula Vista , California
Study Coordinator
GNP Research - Hollywood ( Site 0020)
Cooper City , Florida
Study Coordinator
Arthritis Care of Texas ( Site 0048)
Corpus Christi , Texas
Study Coordinator
Altoona Center for Clinical Research ( Site 0004)
Duncansville , Pennsylvania
Study Coordinator
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
Flagstaff , Arizona
Study Coordinator
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)
Fort Worth , Texas
Study Coordinator
Providence Medical Foundation ( Site 0049)
Fullerton , California
Study Coordinator
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
Gilbert , Arizona
Study Coordinator
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
Glendale , Arizona
Study Coordinator
Provecta Research Network LLC ( Site 0054)
Houston , Texas
Study Coordinator
Newport Huntington Medical Group ( Site 0005)
Huntington Beach , California
Study Coordinator
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)
Irving , Texas
Study Coordinator
Kansas City Physician Partners ( Site 0027)
Kansas City , Missouri
Study Coordinator
Physician Research Collaboration, LLC ( Site 0057)
Lincoln , Nebraska
Study Coordinator
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)
Murfreesboro , Tennessee
Study Coordinator
Innovation Medical Research Center ( Site 0012)
Palmetto Bay , Florida
Study Coordinator
Perelman Center for Advanced Medicine ( Site 0060)
Philadelphia , Pennsylvania
Study Coordinator
Epic Medical Research ( Site 0061)
Red Oak , Texas
Study Coordinator
Arthritis and Rheumatism Associates - Rockville ( Site 0019)
Rockville , Maryland
Study Coordinator
Inspire Santa Fe Medical Group ( Site 0011)
Santa Fe , New Mexico
Study Coordinator
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)
St Louis , Missouri
Study Coordinator
Advanced Rheumatology of Houston ( Site 0001)
The Woodlands , Texas
Study Coordinator
Cohen Medical Centers ( Site 0034)
Thousand Oaks , California
Study Coordinator
DM Clinical Research - TRA ( Site 0010)
Tomball , Texas
Study Coordinator
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
Tucson , Arizona
Study Coordinator
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
Upland , California
Study Coordinator
Willow Rheumatology and Wellness, PLLC ( Site 0035)
Willowbrook , Illinois
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
26.09.2025
Completion date
05.02.2030
Registry ID
NCT07133633
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.