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A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
NCT07176390 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
About this study
This study consists of a 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 72-week Optional Extension
Eligibility criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
* Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
* Has current treatment with oral or parenteral methotrexate (MTX) therapy
* Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS
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 RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA
* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before randomization
* Has any active infection
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Study design
Enrollment target: 182 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-10-08
Estimated completion: 2029-09-03
Last updated: 2026-02-20
Interventions
Drug: TulisokibartDrug: PlaceboDrug: Methotrexate
Primary outcomes
- • Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12 (Week 12)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (61)
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)Recruiting
Glendale, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)Recruiting
Mesa, Arizona, United States
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)Recruiting
La Palma, California, United States
Tekton Research, LLC. ( Site 1008)Recruiting
Fort Collins, Colorado, United States
Sweet Hope Research Specialty, Inc ( Site 1015)Recruiting
Hialeah, Florida, United States
HMD Research LLC ( Site 1016)Recruiting
Orlando, Florida, United States
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)Recruiting
Orland Park, Illinois, United States
AA Medical Research Center ( Site 1027)Recruiting
Grand Blanc, Michigan, United States
Kansas City Physician Partners ( Site 1032)Recruiting
Kansas City, Missouri, United States
Physician Research Collaboration, LLC ( Site 1002)Recruiting
Lincoln, Nebraska, United States
altoona center for clinical research ( Site 1005)Recruiting
Duncansville, Pennsylvania, United States
Rheumatology Specialty Center ( Site 1030)Recruiting
Willow Grove, Pennsylvania, United States
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)Recruiting
Murfreesboro, Tennessee, United States
Rheumatology Associates ( Site 1026)Recruiting
Arlington, Texas, United States
Epic Medical Research ( Site 1004)Recruiting
Red Oak, Texas, United States
Advanced Rheumatology of Houston - Woodlands ( Site 1000)Recruiting
The Woodlands, Texas, United States
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)Recruiting
Sherbrooke, Quebec, Canada
Centre de Recherche Musculo-Squelettique ( Site 1101)Recruiting
Trois-Rivières, Quebec, Canada
Centro de Estudios GyC ( Site 1206)Recruiting
Santiago, Region M. de Santiago, Chile
Clinica Dermacross ( Site 1203)Recruiting
Santiago, Region M. de Santiago, Chile
CECIM ( Site 1208)Recruiting
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)Recruiting
Santiago, Region M. de Santiago, Chile
Peking University First Hospital ( Site 2511)Recruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University. ( Site 2510)Recruiting
Xiamen, Fujian, China
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)Recruiting
Guangzhou, Guangdong, China
Xinxiang Central Hospital ( Site 2501)Recruiting
Xinxiang, Henan, China
Pingxiang People's Hospital ( Site 2512)Recruiting
Pingxiang, Jiangxi, China
Linfen Central Hospital ( Site 2507)Recruiting
Linfen, Shanxi, China
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)Recruiting
Ürümqi, Xinjiang, China
Taizhou Hospital of Zhejiang Province ( Site 2506)Recruiting
Linhai, Zhejiang, China
Clinica de la Costa S.A.S. ( Site 1301)Recruiting
Barranquilla, Atlántico, Colombia
CIREEM SAS ( Site 1304)Recruiting
Bogota, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 1305)Recruiting
Cali, Valle del Cauca Department, Colombia
Medicover München Ost MVZ ( Site 1607)Recruiting
München, Bavaria, Germany
Rheuma-Research Lausitz ( Site 1604)Recruiting
Cottbus, Brandenburg, Germany
Rheumazentrum Ratingen Studienambulanz ( Site 1601)Recruiting
Ratingen, North Rhine-Westphalia, Germany
Rheumatologische Schwerpunktpraxis ( Site 1603)Recruiting
Berlin, Germany
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)Recruiting
Hamburg, Germany
Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)Recruiting
Hanishina-gun, Nagano, Japan
Sasebo Chuo Hospital ( Site 2602)Recruiting
Sasebo, Nagasaki, Japan
Nagaoka Red Cross Hospital ( Site 2604)Recruiting
Nagaoka, Niigata, Japan
Hirose Clinic ( Site 2601)Recruiting
Tokorozawa, Saitama, Japan
University of Yamanashi Hospital ( Site 2603)Recruiting
Chūō, Yamanashi, Japan
Kai Clinic ( Site 2600)Recruiting
Miyazaki, Japan
MICS Centrum Medyczne Bydgoszcz ( Site 1807)Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MICS Centrum Medyczne Torun ( Site 1803)Recruiting
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)Recruiting
Lublin, Lublin Voivodeship, Poland
MICS Centrum Medyczne Warszawa ( Site 1805)Recruiting
Warsaw, Masovian Voivodeship, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)Recruiting
Warsaw, Masovian Voivodeship, Poland
NZOZ BIF-MED ( Site 1802)Recruiting
Bytom, Silesian Voivodeship, Poland
Soon Chun Hyang University Cheonan Hospital ( Site 2304)Recruiting
Cheonan-si, Chungcheongnam-do, South Korea
Chungnam national university hospital ( Site 2303)Recruiting
Daejeon, Taejon-Kwangyokshi, South Korea
Hanyang University Seoul Hospital ( Site 2300)Recruiting
Seoul, South Korea
Hospital Universitari Parc Tauli ( Site 1900)Recruiting
Sabadell, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1906)Recruiting
Santander, Cantabria, Spain
Hospital Clinico Universitario de Santiago ( Site 1903)Recruiting
Santiago de Compostela, La Coruna, Spain
Hospital Universitari Vall d'Hebron ( Site 1901)Recruiting
Barcelona, Spain
The Princess Alexandra Hospital NHS Trust ( Site 2103)Recruiting
Harlow, England, United Kingdom
Chapel Allerton Hospital ( Site 2106)Recruiting
Leeds, United Kingdom
Barnet Hospital ( Site 2102)Recruiting
London, United Kingdom