Recruiting

Phase 2

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07133633

Conditions

Radiographic Axial Spondyloarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tulisokibart

Placebo

Study Details

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

Study ID

NCT07133633

Start date

Sep 26, 2025

Status verified date

Aug, 2026

Completion date

Feb 5, 2030

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

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

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 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

Study Design

Enrollment

315 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: High-dose tulisokibart

Participants receive a high dose of tulisokibart.

experimental: Medium-dose tulisokibart

Participants receive a medium dose of tulisokibart.

experimental: Low-dose tulisokibart

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

placebo comparator: Placebo

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

Interventions

Tulisokibart

Subcutaneous (SC) administration

Placebo

SC administration

Primary outcome measure

Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16 [ Time Frame: Week 16 ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

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

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Study Coordinator

480-443-8400

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

Recruiting

Flagstaff, Arizona, United States, 86001

Contacts

Study Coordinator

480-443-8400

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

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Study Coordinator

480-443-8400

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

Recruiting

Glendale, Arizona, United States, 85306

Contacts

Study Coordinator

480-443-8400

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

Recruiting

Tucson, Arizona, United States, 85704-1140

Contacts

Study Coordinator

480-443-8400

Providence Medical Foundation ( Site 0049)

Recruiting

Fullerton, California, United States, 92835

Contacts

Study Coordinator

714-626-8610

Newport Huntington Medical Group ( Site 0005)

Recruiting

Huntington Beach, California, United States, 92648

Contacts

Study Coordinator

714-378-2440

Cohen Medical Centers ( Site 0034)

Recruiting

Thousand Oaks, California, United States, 91360-3967

Contacts

Study Coordinator

713-487-8680

Inland Rheumatology Clinical Trials, Inc. ( Site 0002)

Recruiting

Upland, California, United States, 91786

Contacts

Study Coordinator

909-296-8700

Arthritis and Rheumatic Disease Specialties ( Site 0016)

Recruiting

Aventura, Florida, United States, 33180

Contacts

Study Coordinator

305-932-4295

Bay Area Arthritis and Osteoporosis ( Site 0041)

Recruiting

Brandon, Florida, United States, 33511

Contacts

Study Coordinator

813-651-4441 Ext 243

GNP Research - Hollywood ( Site 0020)

Recruiting

Cooper City, Florida, United States, 33024

Contacts

Study Coordinator

754-248-3589

Innovation Medical Research Center ( Site 0012)

Recruiting

Palmetto Bay, Florida, United States, 33157

Contacts

Study Coordinator

305-300-2695

Chicago Arthritis & Regenerative Medicine ( Site 0042)

Recruiting

Chicago, Illinois, United States, 60661

Contacts

Study Coordinator

480-443-8400

Willow Rheumatology and Wellness, PLLC ( Site 0035)

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

Study Coordinator

630-537-1313

John Hopkins University ( Site 0052)

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Study Coordinator

410-550-0579

Arthritis and Rheumatism Associates - Rockville ( Site 0019)

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Study Coordinator

301-942-7600

Kansas City Physician Partners ( Site 0027)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-384-2827

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

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Study Coordinator

947-744-6010

Logan Health Rheumatology ( Site 0015)

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Study Coordinator

406-752-2010

Physician Research Collaboration, LLC ( Site 0057)

Recruiting

Lincoln, Nebraska, United States, 68516-5497

Contacts

Study Coordinator

402-420-3442

Inspire Santa Fe Medical Group ( Site 0011)

Recruiting

Santa Fe, New Mexico, United States, 87505

Contacts

Study Coordinator

505-490-5984

Oregon Health & Science University ( Site 0059)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Study Coordinator

503-494-8637

Altoona Center for Clinical Research ( Site 0004)

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Study Coordinator

814-693-0300

Perelman Center for Advanced Medicine ( Site 0060)

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Study Coordinator

215-662-2454

AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)

Recruiting

Murfreesboro, Tennessee, United States, 37128

Contacts

Study Coordinator

615-236-2504

Rheumatology Associates ( Site 0055)

Recruiting

Arlington, Texas, United States, 76012

Contacts

Study Coordinator

214-540-0700

Arthritis Care of Texas ( Site 0048)

Recruiting

Corpus Christi, Texas, United States, 78415

Contacts

Study Coordinator

361-400-7700

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

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

Study Coordinator

301-942-7600

Provecta Research Network LLC ( Site 0054)

Recruiting

Houston, Texas, United States, 77027

Contacts

Study Coordinator

346-735-8990

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

Recruiting

Irving, Texas, United States, 75039

Contacts

Study Coordinator

301-942-7600

Epic Medical Research ( Site 0061)

Recruiting

Red Oak, Texas, United States, 75154

Contacts

Study Coordinator

972-777-6956

Advanced Rheumatology of Houston ( Site 0001)

Recruiting

The Woodlands, Texas, United States, 77382

Contacts

Study Coordinator

936-681-4882

DM Clinical Research - TRA ( Site 0010)

Recruiting

Tomball, Texas, United States, 77375

Contacts

Study Coordinator

346-550-9559

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

Recruiting

Québec, Quebec, Canada, G1V 4K5

Contacts

Study Coordinator

4186502661

Centre de Recherche Musculo-Squelettique ( Site 0202)

Recruiting

Trois-Rivières, Quebec, Canada, G9A 3Y2

Contacts

Study Coordinator

8193701301

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.