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)
Status: Recruiting
Location: See all (89) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Arizona
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)
RECRUITING
Chandler
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)
RECRUITING
Flagstaff
Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)
RECRUITING
Gilbert
AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)
RECRUITING
Glendale
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)
RECRUITING
Tucson
California
TriWest Research Associates - Chula Vista ( Site 0013)
RECRUITING
Chula Vista
Providence Medical Foundation ( Site 0049)
RECRUITING
Fullerton
Newport Huntington Medical Group ( Site 0005)
RECRUITING
Huntington Beach
Cohen Medical Centers ( Site 0034)
RECRUITING
Thousand Oaks
Inland Rheumatology Clinical Trials, Inc. ( Site 0002)
RECRUITING
Upland
Florida
Arthritis and Rheumatic Disease Specialties ( Site 0016)
RECRUITING
Aventura
Bay Area Arthritis and Osteoporosis ( Site 0041)
RECRUITING
Brandon
GNP Research - Hollywood ( Site 0020)
RECRUITING
Cooper City
Innovation Medical Research Center ( Site 0012)
RECRUITING
Palmetto Bay
Illinois
Chicago Arthritis & Regenerative Medicine ( Site 0042)
RECRUITING
Chicago
Willow Rheumatology and Wellness, PLLC ( Site 0035)
RECRUITING
Willowbrook
Maryland
Arthritis and Rheumatism Associates - Rockville ( Site 0019)
RECRUITING
Rockville
Missouri
Kansas City Physician Partners ( Site 0027)
RECRUITING
Kansas City
Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)
RECRUITING
St Louis
Nebraska
Physician Research Collaboration, LLC ( Site 0057)
RECRUITING
Lincoln
New Mexico
Inspire Santa Fe Medical Group ( Site 0011)
RECRUITING
Santa Fe
Pennsylvania
Altoona Center for Clinical Research ( Site 0004)
RECRUITING
Duncansville
Perelman Center for Advanced Medicine ( Site 0060)
RECRUITING
Philadelphia
Tennessee
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)
RECRUITING
Murfreesboro
Texas
Rheumatology Associates ( Site 0055)
RECRUITING
Arlington
Arthritis Care of Texas ( Site 0048)
RECRUITING
Corpus Christi
Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)
RECRUITING
Fort Worth
Provecta Research Network LLC ( Site 0054)
RECRUITING
Houston
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)
RECRUITING
Irving
Epic Medical Research ( Site 0061)
RECRUITING
Red Oak
Advanced Rheumatology of Houston ( Site 0001)
RECRUITING
The Woodlands
DM Clinical Research - TRA ( Site 0010)
RECRUITING
Tomball
Other Locations
Brazil
Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)
RECRUITING
Curitiba
CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)
RECRUITING
Juiz De Fora
IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)
RECRUITING
Rio De Janeiro
Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)
RECRUITING
São Paulo
Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)
RECRUITING
Québec
Centre de Recherche Musculo-Squelettique ( Site 0202)
RECRUITING
Trois-rivières
Chile
Clinica Alemana Osorno ( Site 2114)
RECRUITING
Osorno
Centro de Estudios GyC ( Site 2103)
RECRUITING
Santiago
Enroll SpA ( Site 2101)
RECRUITING
Santiago
China
Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)
RECRUITING
Beijing
The First Afflilated Hospital of Bengbu Medical College ( Site 3119)
RECRUITING
Bengbu
The First Hospital Of Jilin University ( Site 3103)
RECRUITING
Changchun
Guangdong Provincial People's Hospital ( Site 3110)
RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)
RECRUITING
Guangzhou
First Affiliated Hospital of Kunming Medical University ( Site 3123)
RECRUITING
Kunming
The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)
RECRUITING
Luoyang
Pingxiang People's Hospital ( Site 3115)
RECRUITING
Pingxiang
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)
RECRUITING
Ürümqi
Colombia
Clinica de la Costa S.A.S. ( Site 2202)
RECRUITING
Barranquilla
CIREEM SAS ( Site 2204)
RECRUITING
Bogota
Fundación Valle del Lili ( Site 2201)
RECRUITING
Cali
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)
RECRUITING
Berlin
Rheumatologische Schwerpunktpraxis ( Site 0605)
RECRUITING
Berlin
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)
RECRUITING
Hamburg
Medicover München Ost MVZ ( Site 0611)
RECRUITING
Munich
Rheumazentrum Ratingen Studienambulanz ( Site 0602)
RECRUITING
Ratingen
Netherlands
Amsterdam UMC ( Site 1101)
RECRUITING
Amsterdam
Zuyderland Medical Centre ( Site 1100)
RECRUITING
Heerlen
Maasstad Ziekenhuis ( Site 1102)
RECRUITING
Rotterdam
Poland
MICS Centrum Medyczne Bydgoszcz ( Site 1206)
RECRUITING
Bydgoszcz
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)
RECRUITING
Bydgoszcz
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)
RECRUITING
Lublin
MICS Centrum Medyczne Torun ( Site 1202)
RECRUITING
Torun
MICS Centrum Medyczne Warszawa ( Site 1204)
RECRUITING
Warsaw
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)
RECRUITING
Warsaw
Republic of Korea
Hanyang University Seoul Hospital ( Site 2800)
RECRUITING
Seoul
Kyung Hee University Hosptial at Gangdong ( Site 2802)
RECRUITING
Seoul
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)
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Kaohsiung City
Kaohsiung Veterans General Hospital ( Site 2905)
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Kaohsiung City
Taipei Medical University Shuang Ho Hospital ( Site 2900)
RECRUITING
New Taipei City
National Cheng Kung University Hospital ( Site 2903)
RECRUITING
Tainan
Taipei Veterans General Hospital ( Site 2906)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 2902)
RECRUITING
Taipei City
Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)
RECRUITING
Taoyuan District
Turkey
Hacettepe Universite Hastaneleri ( Site 1603)
RECRUITING
Ankara
Ukraine
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)
RECRUITING
Cherkasy
Municipal Non-Profit Enterprise Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council ( Site 1713)
RECRUITING
Khmelnytskiy
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)
RECRUITING
Kyiv
Medical Center of Limited Liability Company Medical Center Consilium Medical ( Site 1715)
RECRUITING
Kyiv
Medical Center Universal Clinic Oberig of Limited Liability Company Kapytal ( Site 1706)
RECRUITING
Kyiv
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)
RECRUITING
Lviv
ME Ternopil Regional Clinical Hospital of Ternopil Regional Council ( Site 1707)
RECRUITING
Ternopil
Municipal Public Non-Profit Enterprise City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)
RECRUITING
Ukraine
Municipal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)
RECRUITING
Vinnytsa
United Kingdom
Barnet Hospital ( Site 1806)
RECRUITING
Barnet
Royal United Hospital Bath NHS Foundation Trust ( Site 1803)
RECRUITING
Bath
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)
RECRUITING
Norwich
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-09-26
Estimated Completion Date: 2030-02-05
Participants
Target number of participants: 315
Treatments
Experimental: High-dose tulisokibart
Participants receive a high dose of tulisokibart.
Experimental: Medium-dose tulisokibart
Participants receive a medium dose of tulisokibart.
Experimental: Low-dose tulisokibart
Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Placebo_comparator: Placebo
Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC