Actively Recruiting
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study Evaluating Tulisokibart for Rheumatoid Arthritis
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
182
Participants Needed
62
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new ways to treat rheumatoid arthritis (RA), especially for people whose symptoms do not respond well to standard treatments like methotrexate (MTX). This study aims to evaluate a medicine called tulisokibart to see if it can reduce active RA symptoms better than a placebo. The study focuses on different doses of tulisokibart to determine which dose might be most effective while participants continue their MTX treatment. Participants will be randomly assigned to receive one of several treatments: MTX plus a high, medium, or low dose of tulisokibart, or MTX plus a placebo that looks like tulisokibart but contains no active medicine. Those on the low dose or placebo will be re-randomized at week 12 to either a medium or high dose of tulisokibart. The study includes a 12-week placebo-controlled period followed by a long-term extension lasting 116 weeks, split into a 44-week main extension and a 72-week optional extension. During the study, participants will have their RA symptoms and response to treatment assessed using criteria such as the American College of Rheumatology 20% response at week 12. Researchers will also monitor safety by recording adverse events and treatment discontinuations up to about week 142. The study involves regular evaluations, including questionnaires and clinical assessments, to track disease activity, physical function, and overall health over the entire study period.
CONDITIONS
Brief Title
A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Clinical diagnosis of rheumatoid arthritis meeting 2010 ACR/EULAR criteria
- Active disease with 6 or more tender joints and 6 or more swollen joints
- Currently treated with oral or injection methotrexate (MTX)
- Biologic disease-modifying antirheumatic drug (bDMARD) naive or inadequate response/intolerance to up to 2 classes of bDMARDs
You will not qualify if you...
- Onset of arthritis before age 17 or diagnosis of inflammatory joint disease other than rheumatoid arthritis
- History of cancer within 5 years except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after surgical removal
- Any active infection at time of screening
- Known allergies, hypersensitivity, or intolerance to tulisokibart or its ingredients
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive background therapy of methotrexate plus randomized doses of tulisokibart or placebo during a 12-week placebo-controlled period.
Duration - 116 weeks
Participants continue treatment in a 116-week long-term extension composed of a 44-week main extension and a 72-week optional extension.
Trial Site Locations
Total: 62 locations
1
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale, Arizona, United States, 85306-9802
Actively Recruiting
2
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa, Arizona, United States, 85210
Actively Recruiting
3
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma, California, United States, 90623
Actively Recruiting
4
Tekton Research, LLC. ( Site 1008)
Fort Collins, Colorado, United States, 80528
Actively Recruiting
5
Sweet Hope Research Specialty, Inc ( Site 1015)
Hialeah, Florida, United States, 33016
Actively Recruiting
6
HMD Research LLC ( Site 1016)
Orlando, Florida, United States, 32819
Actively Recruiting
7
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
Orland Park, Illinois, United States, 60467
Actively Recruiting
8
AA Medical Research Center ( Site 1027)
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
9
Kansas City Physician Partners ( Site 1032)
Kansas City, Missouri, United States, 64111
Actively Recruiting
10
Physician Research Collaboration, LLC ( Site 1002)
Lincoln, Nebraska, United States, 68516
Actively Recruiting
11
altoona center for clinical research ( Site 1005)
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
12
Rheumatology Specialty Center ( Site 1030)
Willow Grove, Pennsylvania, United States, 19090
Actively Recruiting
13
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)
Murfreesboro, Tennessee, United States, 37128
Actively Recruiting
14
Rheumatology Associates ( Site 1026)
Arlington, Texas, United States, 76012
Actively Recruiting
15
Epic Medical Research ( Site 1004)
Red Oak, Texas, United States, 75154
Actively Recruiting
16
Advanced Rheumatology of Houston - Woodlands ( Site 1000)
The Woodlands, Texas, United States, 77382
Actively Recruiting
17
Mount Sinai Hospital ( Site 1102)
Toronto, Ontario, Canada, M5T 3L9
Actively Recruiting
18
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
19
Centre de Recherche Musculo-Squelettique ( Site 1101)
Trois-Rivières, Quebec, Canada, G9A 3X2
Active, Not Recruiting
20
Centro de Estudios GyC ( Site 1206)
Santiago, Region M. de Santiago, Chile, 7500504
Actively Recruiting
21
Clinica Dermacross ( Site 1203)
Santiago, Region M. de Santiago, Chile, 7640881
Actively Recruiting
22
CECIM ( Site 1208)
Santiago, Region M. de Santiago, Chile, 8320000
Actively Recruiting
23
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)
Santiago, Region M. de Santiago, Chile, 8330073
Actively Recruiting
24
Peking University First Hospital ( Site 2511)
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
25
The First Affiliated Hospital of Xiamen University. ( Site 2510)
Xiamen, Fujian, China, 361003
Actively Recruiting
26
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)
Guangzhou, Guangdong, China, 510630
Actively Recruiting
27
Xinxiang Central Hospital ( Site 2501)
Xinxiang, Henan, China, 453000
Actively Recruiting
28
Pingxiang People's Hospital ( Site 2512)
Pingxiang, Jiangxi, China, 337000
Actively Recruiting
29
Linfen Central Hospital ( Site 2507)
Linfen, Shanxi, China, 041000
Actively Recruiting
30
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
31
Taizhou Hospital of Zhejiang Province ( Site 2506)
Linhai, Zhejiang, China, 317000
Actively Recruiting
32
Clinica de la Costa S.A.S. ( Site 1301)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
33
CIREEM SAS ( Site 1304)
Bogota, Cundinamarca, Colombia, 110111
Actively Recruiting
34
Fundación Valle del Lili ( Site 1305)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
35
Medicover München Ost MVZ ( Site 1607)
München, Bavaria, Germany, 81667
Actively Recruiting
36
Rheuma-Research Lausitz ( Site 1604)
Cottbus, Brandenburg, Germany, 03042
Actively Recruiting
37
Rheumazentrum Ratingen Studienambulanz ( Site 1601)
Ratingen, North Rhine-Westphalia, Germany, 40878
Actively Recruiting
38
Rheumatologische Schwerpunktpraxis ( Site 1603)
Berlin, Germany, 12161
Actively Recruiting
39
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)
Hamburg, Germany, 20095
Active, Not Recruiting
40
Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)
Hanishina-gun, Nagano, Japan, 389-0606
Actively Recruiting
41
Sasebo Chuo Hospital ( Site 2602)
Sasebo, Nagasaki, Japan, 857-1195
Actively Recruiting
42
Nagaoka Red Cross Hospital ( Site 2604)
Nagaoka, Niigata, Japan, 940-2085
Actively Recruiting
43
Hirose Clinic ( Site 2601)
Tokorozawa, Saitama, Japan, 359-1111
Actively Recruiting
44
University of Yamanashi Hospital ( Site 2603)
Chūō, Yamanashi, Japan, 409-3898
Actively Recruiting
45
Kai Clinic ( Site 2600)
Miyazaki, Japan, 880-0053
Actively Recruiting
46
MICS Centrum Medyczne Bydgoszcz ( Site 1807)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-065
Actively Recruiting
47
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
Active, Not Recruiting
48
MICS Centrum Medyczne Torun ( Site 1803)
Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
Active, Not Recruiting
49
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)
Lublin, Lublin Voivodeship, Poland, 20-607
Active, Not Recruiting
50
MICS Centrum Medyczne Warszawa ( Site 1805)
Warsaw, Masovian Voivodeship, Poland, 00-874
Actively Recruiting
51
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)
Warsaw, Masovian Voivodeship, Poland, 02-637
Active, Not Recruiting
52
NZOZ BIF-MED ( Site 1802)
Bytom, Silesian Voivodeship, Poland, 41-902
Actively Recruiting
53
Soon Chun Hyang University Cheonan Hospital ( Site 2304)
Cheonan-si, Chungcheongnam-do, South Korea, 31151
Active, Not Recruiting
54
Chungnam national university hospital ( Site 2303)
Daejeon, Taejon-Kwangyokshi, South Korea, 35015
Actively Recruiting
55
Hanyang University Seoul Hospital ( Site 2300)
Seoul, South Korea, 04763
Actively Recruiting
56
Hospital Universitari Parc Tauli ( Site 1900)
Sabadell, Barcelona, Spain, 8208
Active, Not Recruiting
57
Hospital Universitario Marqués de Valdecilla ( Site 1906)
Santander, Cantabria, Spain, 39008
Active, Not Recruiting
58
Hospital Clinico Universitario de Santiago ( Site 1903)
Santiago de Compostela, La Coruna, Spain, 15706
Active, Not Recruiting
59
Hospital Universitari Vall d'Hebron ( Site 1901)
Barcelona, Spain, 08035
Active, Not Recruiting
60
The Princess Alexandra Hospital NHS Trust ( Site 2103)
Harlow, England, United Kingdom, CM20 1QX
Actively Recruiting
61
Chapel Allerton Hospital ( Site 2106)
Leeds, United Kingdom, LS7 4SA
Actively Recruiting
62
Barnet Hospital ( Site 2102)
London, United Kingdom, EN5 3DJ
Active, Not Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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