A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)

Last updated: April 22, 2026
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Rheumatoid Arthritis

Treatment

Tulisokibart

Methotrexate

Placebo

Clinical Study ID

NCT07176390
7240-014
MK-7240-014
2025-521745-25-00
U1111-1320-8718
  • Ages 18-80
  • All Genders

Study Summary

Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people.

This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart.

Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA 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 Criteria

Inclusion

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 2010American 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 swollenjoints (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 antirheumaticdrug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to amaximum of 2 classes of bDMARDS

Exclusion

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 ofinflammatory joint disease other than RA (such as, but not limited to, psoriaticarthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis,pseudogout, etc) or any other condition that may, in the judgment of theinvestigator, interfere with the assessment of RA

  • Has a history of cancer (except fully treated nonmelanoma skin cancers or cervicalcarcinoma in situ after complete surgical removal) and is disease free for <5 yearsbefore randomization

  • Has any active infection

  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or itsexcipients

Study Design

Total Participants: 182
Treatment Group(s): 3
Primary Treatment: Tulisokibart
Phase: 2
Study Start date:
October 08, 2025
Estimated Completion Date:
September 03, 2029

Study Description

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

Connect with a study center

  • Mount Sinai Hospital ( Site 1102)

    Toronto, Ontario M5T 3L9
    Canada

    Active - Recruiting

  • CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)

    Sherbrooke, Quebec J1G 2E8
    Canada

    Active - Recruiting

  • Centre de Recherche Musculo-Squelettique ( Site 1101)

    Trois-Rivières, Quebec G9A 3X2
    Canada

    Active - Recruiting

  • CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)

    Sherbrooke 6146143, Quebec 6115047 J1G 2E8
    Canada

    Site Not Available

  • Centre de Recherche Musculo-Squelettique ( Site 1101)

    Trois-Rivières 6169141, Quebec 6115047 G9A 3X2
    Canada

    Site Not Available

  • CECIM ( Site 1208)

    Santiago, Region M. de Santiago 8320000
    Chile

    Active - Recruiting

  • Centro de Estudios GyC ( Site 1206)

    Santiago, Region M. de Santiago 7500504
    Chile

    Active - Recruiting

  • Clinica Dermacross ( Site 1203)

    Santiago, Region M. de Santiago 7640881
    Chile

    Active - Recruiting

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)

    Santiago, Region M. de Santiago 8330073
    Chile

    Active - Recruiting

  • CECIM ( Site 1208)

    Santiago 3871336, Region M. de Santiago 8320000
    Chile

    Active - Recruiting

  • Centro de Estudios GyC ( Site 1206)

    Santiago 3871336, Region M. de Santiago 7500504
    Chile

    Active - Recruiting

  • Clinica Dermacross ( Site 1203)

    Santiago 3871336, Region M. de Santiago 7640881
    Chile

    Active - Recruiting

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)

    Santiago 3871336, Region M. de Santiago 8330073
    Chile

    Site Not Available

  • Peking University First Hospital ( Site 2511)

    Beijing, Beijing Municipality 100034
    China

    Active - Recruiting

  • Peking University First Hospital ( Site 2511)

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University. ( Site 2510)

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University. ( Site 2510)

    Xiamen 1790645, Fujian 1811017 361003
    China

    Site Not Available

  • The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)

    Guangzhou 1809858, Guangdong 1809935 510630
    China

    Site Not Available

  • Xinxiang Central Hospital ( Site 2501)

    Xinxiang, Henan 453000
    China

    Active - Recruiting

  • Xinxiang Central Hospital ( Site 2501)

    Xinxiang 1788572, Henan 1808520 453000
    China

    Site Not Available

  • Pingxiang People's Hospital ( Site 2512)

    Pingxiang, Jiangxi 337000
    China

    Active - Recruiting

  • Pingxiang People's Hospital ( Site 2512)

    Pingxiang 1798654, Jiangxi 1806222 337000
    China

    Site Not Available

  • Linfen Central Hospital ( Site 2507)

    Linfen, Shanxi 041000
    China

    Active - Recruiting

  • Linfen Central Hospital ( Site 2507)

    Linfen 1803567, Shanxi 1795912 041000
    China

    Site Not Available

  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)

    Ürümqi, Xinjiang 830001
    China

    Active - Recruiting

  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)

    Ürümqi 1529102, Xinjiang 1529047 830001
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province ( Site 2506)

    Linhai, Zhejiang 317000
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 2506)

    Linhai 1803422, Zhejiang 1784764 317000
    China

    Site Not Available

  • Clinica de la Costa S.A.S. ( Site 1301)

    Barranquilla, Atlántico 080020
    Colombia

    Active - Recruiting

  • Clinica de la Costa S.A.S. ( Site 1301)

    Barranquilla 3689147, Atlántico 3689436 080020
    Colombia

    Site Not Available

  • CIREEM SAS ( Site 1304)

    Bogota, Cundinamarca 110111
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 1305)

    Cali, Valle del Cauca Department 760032
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 1305)

    Cali 3687925, Valle del Cauca Department 3666313 760032
    Colombia

    Site Not Available

  • Medicover München Ost MVZ ( Site 1607)

    München, Bavaria 81667
    Germany

    Active - Recruiting

  • Medicover München Ost MVZ ( Site 1607)

    München 2867713, Bavaria 2951839 81667
    Germany

    Site Not Available

  • Rheuma-Research Lausitz ( Site 1604)

    Cottbus, Brandenburg 03042
    Germany

    Active - Recruiting

  • Rheuma-Research Lausitz ( Site 1604)

    Cottbus 2939811, Brandenburg 2945356 03042
    Germany

    Site Not Available

  • Rheumazentrum Ratingen Studienambulanz ( Site 1601)

    Ratingen, North Rhine-Westphalia 40878
    Germany

    Active - Recruiting

  • Rheumazentrum Ratingen Studienambulanz ( Site 1601)

    Ratingen 2850174, North Rhine-Westphalia 2861876 40878
    Germany

    Site Not Available

  • Rheumatologische Schwerpunktpraxis ( Site 1603)

    Berlin, 12161
    Germany

    Active - Recruiting

  • Rheumatologische Schwerpunktpraxis ( Site 1603)

    Berlin 2950159, 12161
    Germany

    Site Not Available

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)

    Hamburg, 20095
    Germany

    Active - Recruiting

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)

    Hamburg 2911298, 20095
    Germany

    Site Not Available

  • Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)

    Hanishina-gun, Nagano 389-0606
    Japan

    Active - Recruiting

  • Sasebo Chuo Hospital ( Site 2602)

    Sasebo, Nagasaki 857-1195
    Japan

    Active - Recruiting

  • Sasebo Chuo Hospital ( Site 2602)

    Sasebo 1852899, Nagasaki 1856156 857-1195
    Japan

    Site Not Available

  • Nagaoka Red Cross Hospital ( Site 2604)

    Nagaoka, Niigata 940-2085
    Japan

    Active - Recruiting

  • Nagaoka Red Cross Hospital ( Site 2604)

    Nagaoka 1856199, Niigata 1855429 940-2085
    Japan

    Site Not Available

  • Hirose Clinic ( Site 2601)

    Tokorozawa, Saitama 359-1111
    Japan

    Active - Recruiting

  • Hirose Clinic ( Site 2601)

    Tokorozawa 1850181, Saitama 1853226 359-1111
    Japan

    Site Not Available

  • University of Yamanashi Hospital ( Site 2603)

    Chūō, Yamanashi 409-3898
    Japan

    Active - Recruiting

  • University of Yamanashi Hospital ( Site 2603)

    Chūō 11612585, Yamanashi 1848649 409-3898
    Japan

    Site Not Available

  • Kai Clinic ( Site 2600)

    Miyazaki, 880-0053
    Japan

    Active - Recruiting

  • Kai Clinic ( Site 2600)

    Miyazaki 1856717, 880-0053
    Japan

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz ( Site 1807)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-065
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Torun ( Site 1803)

    Torun, Kuyavian-Pomeranian Voivodeship 87-100
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Bydgoszcz ( Site 1807)

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-065
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-168
    Poland

    Site Not Available

  • MICS Centrum Medyczne Torun ( Site 1803)

    Torun 3083271, Kuyavian-Pomeranian Voivodeship 3337500 87-100
    Poland

    Site Not Available

  • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)

    Lublin, Lublin Voivodeship 20-607
    Poland

    Active - Recruiting

  • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)

    Lublin 765876, Lublin Voivodeship 858785 20-607
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa ( Site 1805)

    Warsaw, Masovian Voivodeship 00-874
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)

    Warsaw, Masovian Voivodeship 02-637
    Poland

    Active - Recruiting

  • MICS Centrum Medyczne Warszawa ( Site 1805)

    Warsaw 756135, Masovian Voivodeship 858787 00-874
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)

    Warsaw 756135, Masovian Voivodeship 858787 02-637
    Poland

    Active - Recruiting

  • NZOZ BIF-MED ( Site 1802)

    Bytom, Silesian Voivodeship 41-902
    Poland

    Active - Recruiting

  • NZOZ BIF-MED ( Site 1802)

    Bytom 3101950, Silesian Voivodeship 3337497 41-902
    Poland

    Site Not Available

  • Soon Chun Hyang University Cheonan Hospital ( Site 2304)

    Cheonan-si, Chungcheongnam-do 31151
    South Korea

    Active - Recruiting

  • Chungnam national university hospital ( Site 2303)

    Daejeon, Taejon-Kwangyokshi 35015
    South Korea

    Active - Recruiting

  • Chungnam national university hospital ( Site 2303)

    Daejeon 1835235, Taejon-Kwangyokshi 35015
    South Korea

    Site Not Available

  • Hanyang University Seoul Hospital ( Site 2300)

    Seoul, 04763
    South Korea

    Active - Recruiting

  • Hanyang University Seoul Hospital ( Site 2300)

    Seoul 1835848, 04763
    South Korea

    Site Not Available

  • Hospital Universitari Parc Tauli ( Site 1900)

    Sabadell, Barcelona 8208
    Spain

    Active - Recruiting

  • Hospital Universitari Parc Tauli ( Site 1900)

    Sabadell 3111199, Barcelona 8208
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla ( Site 1906)

    Santander, Cantabria 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla ( Site 1906)

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Santiago ( Site 1903)

    Santiago de Compostela, La Coruna 15706
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago ( Site 1903)

    Santiago de Compostela 3109642, La Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron ( Site 1901)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1901)

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • The Princess Alexandra Hospital NHS Trust ( Site 2103)

    Harlow, England CM20 1QX
    United Kingdom

    Active - Recruiting

  • The Princess Alexandra Hospital NHS Trust ( Site 2103)

    Harlow 2647461, England 6269131 CM20 1QX
    United Kingdom

    Site Not Available

  • Chapel Allerton Hospital ( Site 2106)

    Leeds, LS7 4SA
    United Kingdom

    Active - Recruiting

  • Chapel Allerton Hospital ( Site 2106)

    Leeds 2644688, LS7 4SA
    United Kingdom

    Site Not Available

  • Barnet Hospital ( Site 2102)

    London, EN5 3DJ
    United Kingdom

    Active - Recruiting

  • Barnet Hospital ( Site 2102)

    London 2643743, EN5 3DJ
    United Kingdom

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)

    Glendale, Arizona 85306-9802
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)

    Mesa, Arizona 85210
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)

    Glendale 5295985, Arizona 5551752 85306-9802
    United States

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)

    Mesa 5304391, Arizona 5551752 85210
    United States

    Site Not Available

  • Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)

    La Palma, California 90623
    United States

    Active - Recruiting

  • Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)

    La Palma 5364022, California 5332921 90623
    United States

    Site Not Available

  • Tekton Research, LLC. ( Site 1008)

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Tekton Research, LLC. ( Site 1008)

    Fort Collins 5577147, Colorado 5417618 80528
    United States

    Site Not Available

  • Sweet Hope Research Specialty, Inc ( Site 1015)

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • HMD Research LLC ( Site 1016)

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Sweet Hope Research Specialty, Inc ( Site 1015)

    Hialeah 4158476, Florida 4155751 33016
    United States

    Site Not Available

  • HMD Research LLC ( Site 1016)

    Orlando 4167147, Florida 4155751 32819
    United States

    Site Not Available

  • Greater Chicago Specialty Physicians - Orland Park ( Site 1043)

    Orland Park, Illinois 60467
    United States

    Active - Recruiting

  • Greater Chicago Specialty Physicians - Orland Park ( Site 1043)

    Orland Park 4904937, Illinois 4896861 60467
    United States

    Site Not Available

  • AA Medical Research Center ( Site 1027)

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • AA Medical Research Center ( Site 1027)

    Grand Blanc 4994320, Michigan 5001836 48439
    United States

    Site Not Available

  • Kansas City Physician Partners ( Site 1032)

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Kansas City Physician Partners ( Site 1032)

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Site Not Available

  • Physician Research Collaboration, LLC ( Site 1002)

    Lincoln, Nebraska 68516
    United States

    Active - Recruiting

  • Physician Research Collaboration, LLC ( Site 1002)

    Lincoln 5072006, Nebraska 5073708 68516
    United States

    Site Not Available

  • altoona center for clinical research ( Site 1005)

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Rheumatology Specialty Center ( Site 1030)

    Willow Grove, Pennsylvania 19090
    United States

    Active - Recruiting

  • altoona center for clinical research ( Site 1005)

    Duncansville 5187508, Pennsylvania 6254927 16635
    United States

    Site Not Available

  • Rheumatology Specialty Center ( Site 1030)

    Willow Grove 5219619, Pennsylvania 6254927 19090
    United States

    Site Not Available

  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)

    Murfreesboro, Tennessee 37128
    United States

    Active - Recruiting

  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)

    Murfreesboro 4644312, Tennessee 4662168 37128
    United States

    Site Not Available

  • Rheumatology Associates ( Site 1026)

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Epic Medical Research ( Site 1004)

    Red Oak, Texas 75154
    United States

    Active - Recruiting

  • Advanced Rheumatology of Houston - Woodlands ( Site 1000)

    The Woodlands, Texas 77382
    United States

    Active - Recruiting

  • Rheumatology Associates ( Site 1026)

    Arlington 4671240, Texas 4736286 76012
    United States

    Site Not Available

  • Epic Medical Research ( Site 1004)

    Red Oak 4721921, Texas 4736286 75154
    United States

    Site Not Available

  • Advanced Rheumatology of Houston - Woodlands ( Site 1000)

    The Woodlands 4736476, Texas 4736286 77382
    United States

    Site Not Available

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