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

NCT07176390 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 7240-014U1111-1320-87182025-521745-25-00MK-7240-014
• Study Type: interventional
• Target: 182
• Locations: 11 countries
• Sites: 62

Brief 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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12

  The ACR20 response is a composite measure to evaluate disease activity in RA. ACR20 response is defined as a ≥20% improvement in: a) swollen joint count (66 joints) and tender joint count (68 joints) (0= Absent; 1= Present) and b) ≥20% improvement in ≥3 of the following 5 assessments and questionnaires: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do) a higher score=worse disability, ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active) a higher score= more active disease; iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active) a higher score= more active disease; iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain) a higher score = more pain; v) High-sensitivity C-reactive protein (hsCRP) serum values, a lower value indicates less inflammation. The proportion of participants with ACR20 response at Week 12 will be presented.

  Week 12

Secondary Outcomes (6)

• Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12

  Week 12

• Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12

  Week 12

• Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)

  Week 12

• Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12

  Baseline and Week 12

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately Week 142

Study Arms (4)

High-dose tulisokibart

EXPERIMENTAL

Participants receive background therapy of methotrexate (MTX) PLUS a high dose of tulisokibart

Drug: Tulisokibart; Drug: Methotrexate

Medium-dose tulisokibart

EXPERIMENTAL

Participants receive background therapy of MTX PLUS a medium dose of tulisokibart.

Drug: Tulisokibart; Drug: Methotrexate

Low-dose tulisokibart

EXPERIMENTAL

Participants receive background therapy of MTX PLUS a low dose of tulisokibart and are rerandomized at week 12 to a medium or high dose of tulisokibart.

Drug: Tulisokibart; Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

Participants receive background therapy of MTX PLUS a dose-matched tulisokibart placebo and are re-randomized at week 12 to a medium or high dose of tulisokibart.

Drug: Placebo; Drug: Methotrexate

Interventions

Tulisokibart DRUG

Subcutaneous (SC) administration

Also known as: MK-7240, PRA023

High-dose tulisokibart; Low-dose tulisokibart; Medium-dose tulisokibart

Placebo DRUG

SC Injection

Placebo

Methotrexate DRUG

Background Therapy - SC injection or oral administration. Per protocol, parenteral administration is allowed.

Also known as: MTX

High-dose tulisokibart; Low-dose tulisokibart; Medium-dose tulisokibart; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (62)

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

Glendale, Arizona, 85306-9802, United States

RECRUITING

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

Mesa, Arizona, 85210, United States

RECRUITING

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

La Palma, California, 90623, United States

RECRUITING

Tekton Research, LLC. ( Site 1008)

Fort Collins, Colorado, 80528, United States

RECRUITING

Sweet Hope Research Specialty, Inc ( Site 1015)

Hialeah, Florida, 33016, United States

RECRUITING

HMD Research LLC ( Site 1016)

Orlando, Florida, 32819, United States

RECRUITING

Greater Chicago Specialty Physicians - Orland Park ( Site 1043)

Orland Park, Illinois, 60467, United States

RECRUITING

AA Medical Research Center ( Site 1027)

Grand Blanc, Michigan, 48439, United States

RECRUITING

Kansas City Physician Partners ( Site 1032)

Kansas City, Missouri, 64111, United States

RECRUITING

Physician Research Collaboration, LLC ( Site 1002)

Lincoln, Nebraska, 68516, United States

RECRUITING

altoona center for clinical research ( Site 1005)

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Rheumatology Specialty Center ( Site 1030)

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)

Murfreesboro, Tennessee, 37128, United States

RECRUITING

Rheumatology Associates ( Site 1026)

Arlington, Texas, 76012, United States

RECRUITING

Epic Medical Research ( Site 1004)

Red Oak, Texas, 75154, United States

RECRUITING

Advanced Rheumatology of Houston - Woodlands ( Site 1000)

The Woodlands, Texas, 77382, United States

RECRUITING

Mount Sinai Hospital ( Site 1102)

Toronto, Ontario, M5T 3L9, Canada

RECRUITING

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

Sherbrooke, Quebec, J1G 2E8, Canada

RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 1101)

Trois-Rivières, Quebec, G9A 3X2, Canada

RECRUITING

Centro de Estudios GyC ( Site 1206)

Santiago, Region M. de Santiago, 7500504, Chile

RECRUITING

Clinica Dermacross ( Site 1203)

Santiago, Region M. de Santiago, 7640881, Chile

RECRUITING

CECIM ( Site 1208)

Santiago, Region M. de Santiago, 8320000, Chile

RECRUITING

Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)

Santiago, Region M. de Santiago, 8330073, Chile

RECRUITING

Peking University First Hospital ( Site 2511)

Beijing, Beijing Municipality, 100034, China

RECRUITING

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

Xiamen, Fujian, 361003, China

RECRUITING

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

Guangzhou, Guangdong, 510630, China

RECRUITING

Xinxiang Central Hospital ( Site 2501)

Xinxiang, Henan, 453000, China

RECRUITING

Pingxiang People's Hospital ( Site 2512)

Pingxiang, Jiangxi, 337000, China

RECRUITING

Linfen Central Hospital ( Site 2507)

Linfen, Shanxi, 041000, China

RECRUITING

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

Ürümqi, Xinjiang, 830001, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 2506)

Linhai, Zhejiang, 317000, China

RECRUITING

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

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

CIREEM SAS ( Site 1304)

Bogota, Cundinamarca, 110111, Colombia

RECRUITING

Fundación Valle del Lili ( Site 1305)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Medicover München Ost MVZ ( Site 1607)

München, Bavaria, 81667, Germany

RECRUITING

Rheuma-Research Lausitz ( Site 1604)

Cottbus, Brandenburg, 03042, Germany

RECRUITING

Rheumazentrum Ratingen Studienambulanz ( Site 1601)

Ratingen, North Rhine-Westphalia, 40878, Germany

RECRUITING

Rheumatologische Schwerpunktpraxis ( Site 1603)

Berlin, 12161, Germany

RECRUITING

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

Hamburg, 20095, Germany

RECRUITING

Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)

Hanishina-gun, Nagano, 389-0606, Japan

RECRUITING

Sasebo Chuo Hospital ( Site 2602)

Sasebo, Nagasaki, 857-1195, Japan

RECRUITING

Nagaoka Red Cross Hospital ( Site 2604)

Nagaoka, Niigata, 940-2085, Japan

RECRUITING

Hirose Clinic ( Site 2601)

Tokorozawa, Saitama, 359-1111, Japan

RECRUITING

University of Yamanashi Hospital ( Site 2603)

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

Kai Clinic ( Site 2600)

Miyazaki, 880-0053, Japan

RECRUITING

MICS Centrum Medyczne Bydgoszcz ( Site 1807)

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

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

RECRUITING

MICS Centrum Medyczne Torun ( Site 1803)

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

RECRUITING

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

Lublin, Lublin Voivodeship, 20-607, Poland

RECRUITING

MICS Centrum Medyczne Warszawa ( Site 1805)

Warsaw, Masovian Voivodeship, 00-874, Poland

RECRUITING

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

NZOZ BIF-MED ( Site 1802)

Bytom, Silesian Voivodeship, 41-902, Poland

RECRUITING

Soon Chun Hyang University Cheonan Hospital ( Site 2304)

Cheonan-si, Chungcheongnam-do, 31151, South Korea

RECRUITING

Chungnam national university hospital ( Site 2303)

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

RECRUITING

Hanyang University Seoul Hospital ( Site 2300)

Seoul, 04763, South Korea

RECRUITING

Hospital Universitari Parc Tauli ( Site 1900)

Sabadell, Barcelona, 8208, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla ( Site 1906)

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Clinico Universitario de Santiago ( Site 1903)

Santiago de Compostela, La Coruna, 15706, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 1901)

Barcelona, 08035, Spain

RECRUITING

The Princess Alexandra Hospital NHS Trust ( Site 2103)

Harlow, England, CM20 1QX, United Kingdom

RECRUITING

Chapel Allerton Hospital ( Site 2106)

Leeds, LS7 4SA, United Kingdom

RECRUITING

Barnet Hospital ( Site 2102)

London, EN5 3DJ, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): September 3, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (3); US (16); CN (8); CA (3); DE (5); PL (7); KR (3); CO (3); CL (4); ES (4); JP (6)