A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)

NCT07133633 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 7240-0132025-521059-21-00U1111-1318-5807MK-7240-013
• Study Type: interventional
• Target: 315
• Locations: 14 countries
• Sites: 95

Brief 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.

Conditions

Radiographic Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16

  ASAS 40 is defined as a relative improvement of ≥40% and an absolute improvement of ≥2 units from baseline in ≥3 of 4 domains, with no deterioration in the fourth domain. The 4 domains include Patient Global Assessment (PtGA), total spinal pain, physical function, and morning stiffness. Each domain is measured on a 10-point numeric scale from 0 = no disease symptoms/impact to 10 = extreme disease symptoms/impact, with a higher score indicating more severe impairment.

  Week 16

Secondary Outcomes (14)

• Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16

  Week 16

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16

  Baseline and Week 16

• Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Spine at Week 16

  Baseline and Week 16

• Change From Baseline in the SPARCC MRI Score for Sacroiliac Joint (SIJ) at Week 16

  Baseline and Week 16

• Change From Baseline in Total Spinal Pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at Week 16

  Baseline and Week 16

Study Arms (4)

High-dose tulisokibart

EXPERIMENTAL

Participants receive a high dose of tulisokibart.

Drug: Tulisokibart

Medium-dose tulisokibart

EXPERIMENTAL

Participants receive a medium dose of tulisokibart.

Drug: Tulisokibart

Low-dose tulisokibart

EXPERIMENTAL

Participants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.

Drug: Tulisokibart

Placebo

PLACEBO COMPARATOR

Participants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.

Drug: Placebo

Interventions

Tulisokibart DRUG

Subcutaneous (SC) administration

Also known as: MK-7240, PRA023

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

Placebo DRUG

SC administration

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 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

You may not qualify if:

• Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA
• Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
• Has any active infection
• Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (95)

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)

Chandler, Arizona, 85225, United States

RECRUITING

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)

Flagstaff, Arizona, 86001, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)

Gilbert, Arizona, 85297, United States

RECRUITING

AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)

Glendale, Arizona, 85306, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)

Tucson, Arizona, 85704-1140, United States

RECRUITING

TriWest Research Associates - Chula Vista ( Site 0013)

Chula Vista, California, 91910, United States

RECRUITING

Providence Medical Foundation ( Site 0049)

Fullerton, California, 92835, United States

RECRUITING

Newport Huntington Medical Group ( Site 0005)

Huntington Beach, California, 92648, United States

RECRUITING

Cohen Medical Centers ( Site 0034)

Thousand Oaks, California, 91360-3967, United States

RECRUITING

Inland Rheumatology Clinical Trials, Inc. ( Site 0002)

Upland, California, 91786, United States

RECRUITING

Arthritis and Rheumatic Disease Specialties ( Site 0016)

Aventura, Florida, 33180, United States

RECRUITING

Bay Area Arthritis and Osteoporosis ( Site 0041)

Brandon, Florida, 33511, United States

RECRUITING

GNP Research - Hollywood ( Site 0020)

Cooper City, Florida, 33024, United States

RECRUITING

Innovation Medical Research Center ( Site 0012)

Palmetto Bay, Florida, 33157, United States

RECRUITING

Chicago Arthritis & Regenerative Medicine ( Site 0042)

Chicago, Illinois, 60661, United States

RECRUITING

Willow Rheumatology and Wellness, PLLC ( Site 0035)

Willowbrook, Illinois, 60527, United States

RECRUITING

Arthritis and Rheumatism Associates - Rockville ( Site 0019)

Rockville, Maryland, 20850, United States

RECRUITING

Kansas City Physician Partners ( Site 0027)

Kansas City, Missouri, 64111, United States

RECRUITING

Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)

St Louis, Missouri, 63131, United States

RECRUITING

Physician Research Collaboration, LLC ( Site 0057)

Lincoln, Nebraska, 68516-5497, United States

RECRUITING

Inspire Santa Fe Medical Group ( Site 0011)

Santa Fe, New Mexico, 87505, United States

RECRUITING

Altoona Center for Clinical Research ( Site 0004)

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Perelman Center for Advanced Medicine ( Site 0060)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)

Murfreesboro, Tennessee, 37128, United States

RECRUITING

Rheumatology Associates ( Site 0055)

Arlington, Texas, 76012, United States

RECRUITING

Arthritis Care of Texas ( Site 0048)

Corpus Christi, Texas, 78415, United States

RECRUITING

Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)

Fort Worth, Texas, 76109, United States

RECRUITING

Provecta Research Network LLC ( Site 0054)

Houston, Texas, 77027, United States

RECRUITING

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)

Irving, Texas, 75039, United States

RECRUITING

Epic Medical Research ( Site 0061)

Red Oak, Texas, 75154, United States

RECRUITING

Advanced Rheumatology of Houston ( Site 0001)

The Woodlands, Texas, 77382, United States

RECRUITING

DM Clinical Research - TRA ( Site 0010)

Tomball, Texas, 77375, United States

RECRUITING

CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)

Juiz de Fora, Minas Gerais, 36010-570, Brazil

RECRUITING

Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)

Curitiba, Paraná, 80060-900, Brazil

RECRUITING

LMK Serviços Médicos S/S ( Site 2000)

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

RECRUITING

IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)

Rio de Janeiro, 20241-180, Brazil

RECRUITING

Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)

São Paulo, 05403-000, Brazil

RECRUITING

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)

Québec, Quebec, G1V 3M7, Canada

RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 0202)

Trois-Rivières, Quebec, G9A 3Y2, Canada

RECRUITING

Clinica Alemana Osorno ( Site 2114)

Osorno, Los Lagos Region, 5311089, Chile

RECRUITING

Centro de Estudios GyC ( Site 2103)

Santiago, Region M. de Santiago, 7500504, Chile

RECRUITING

Enroll SpA ( Site 2101)

Santiago, Region M. de Santiago, 7500587, Chile

RECRUITING

The First Afflilated Hospital of Bengbu Medical College ( Site 3119)

Bengbu, Anhui, 233004, China

RECRUITING

Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)

Beijing, Beijing Municipality, 100005, China

RECRUITING

Guangdong Provincial People's Hospital ( Site 3110)

Guangzhou, Guangdong, 510080, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)

Guangzhou, Guangdong, 510630, China

RECRUITING

The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)

Luoyang, Henan, 471003, China

RECRUITING

Pingxiang People's Hospital ( Site 3115)

Pingxiang, Jiangxi, 337055, China

RECRUITING

The First Hospital Of Jilin University ( Site 3103)

Changchun, Jilin, 130021, China

RECRUITING

PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)

Ürümqi, Xinjiang, 830001, China

RECRUITING

First Affiliated Hospital of Kunming Medical University ( Site 3123)

Kunming, Yunnan, 650032, China

RECRUITING

Clinica de la Costa S.A.S. ( Site 2202)

Barranquilla, Atlántico, 080020, Colombia

RECRUITING

CIREEM SAS ( Site 2204)

Bogota, Cundinamarca, 110221, Colombia

ACTIVE NOT RECRUITING

Fundación Valle del Lili ( Site 2201)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Medicover München Ost MVZ ( Site 0611)

Munich, Bavaria, 81667, Germany

RECRUITING

Rheumazentrum Ruhrgebiet ( Site 0600)

Herne, North Rhine-Westphalia, 44649, Germany

RECRUITING

Rheumazentrum Ratingen Studienambulanz ( Site 0602)

Ratingen, North Rhine-Westphalia, 40878, Germany

RECRUITING

Rheumatologische Schwerpunktpraxis ( Site 0605)

Berlin, 12161, Germany

RECRUITING

Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)

Berlin, 12203, Germany

RECRUITING

HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)

Hamburg, 20095, Germany

RECRUITING

Zuyderland Medical Centre ( Site 1100)

Heerlen, Limburg, 6419 PC, Netherlands

RECRUITING

Amsterdam UMC ( Site 1101)

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Maasstad Ziekenhuis ( Site 1102)

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

MICS Centrum Medyczne Bydgoszcz ( Site 1206)

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

RECRUITING

Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)

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

RECRUITING

MICS Centrum Medyczne Torun ( Site 1202)

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

RECRUITING

Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)

Lublin, Lublin Voivodeship, 20-607, Poland

RECRUITING

MICS Centrum Medyczne Warszawa ( Site 1204)

Warsaw, Masovian Voivodeship, 00-874, Poland

RECRUITING

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

Hanyang University Seoul Hospital ( Site 2800)

Seoul, 04763, South Korea

RECRUITING

Kyung Hee University Hosptial at Gangdong ( Site 2802)

Seoul, 05278, South Korea

RECRUITING

Taipei Medical University Shuang Ho Hospital ( Site 2900)

New Taipei City, New Taipei, 235, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 2902)

Taipei City, Taipei, 100, Taiwan

RECRUITING

Kaohsiung Veterans General Hospital ( Site 2905)

Kaohsiung City, 813414, Taiwan

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)

Kaohsiung City, 833, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2903)

Tainan, 704, Taiwan

RECRUITING

Taipei Veterans General Hospital ( Site 2906)

Taipei, 112, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)

Taoyuan District, 33305, Taiwan

RECRUITING

Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)

Fatih, Istanbul, 34098, Turkey (Türkiye)

RECRUITING

ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri ( Site 1603)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Konya Necmettin Erbakan Universitesi ( Site 1606)

Konya, 42090, Turkey (Türkiye)

RECRUITING

Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)

Cherkasy, Chernivetska Oblast, 18009, Ukraine

RECRUITING

Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)

Ukraine, Ivano-Frankivsk Oblast, 76018, Ukraine

RECRUITING

Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)

Khmelnytskiy, Khmelnytskyi Oblast, 29000, Ukraine

RECRUITING

Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)

Kyiv, Kyivska Oblast, 04050, Ukraine

RECRUITING

Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)

Lviv, Lviv Oblast, 79011, Ukraine

RECRUITING

ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)

Ternopil, Ternopil Oblast, 46002, Ukraine

RECRUITING

Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)

Vinnytsa, Vinnytsia Oblast, 21018, Ukraine

RECRUITING

Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)

Kyiv, 03049, Ukraine

RECRUITING

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)

Kyiv, 03057, Ukraine

RECRUITING

Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

Royal United Hospital Bath NHS Foundation Trust ( Site 1803)

Bath, Somerset, BA1 3NG, United Kingdom

RECRUITING

Barnet Hospital ( Site 1806)

Barnet, EN5 3DJ, United Kingdom

RECRUITING

St Luke's Hospital ( Site 1801)

Bradford, BD5 0NA, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): February 5, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (7); CA (2); NL (3); CL (3); DE (6); PL (6); KR (2); US (32); CN (9); UA (9); TU (4); CO (3); GB (4); BR (5)