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

NCT ID: NCT07133633

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-26

Study Completion Date

2030-02-05

Brief Summary

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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.

Detailed Description

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This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional Extension.

Conditions

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Radiographic Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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High-dose tulisokibart

Participants receive a high dose of tulisokibart.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Medium-dose tulisokibart

Participants receive a medium dose of tulisokibart.

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Low-dose tulisokibart

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

Group Type EXPERIMENTAL

Tulisokibart

Intervention Type DRUG

Subcutaneous (SC) administration

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC administration

Interventions

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Tulisokibart

Subcutaneous (SC) administration

Intervention Type DRUG

Placebo

SC administration

Intervention Type DRUG

Other Intervention Names

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MK-7240 PRA023

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Tucson, Arizona, United States

Site Status RECRUITING

Cohen Medical Centers ( Site 0034)

Thousand Oaks, California, United States

Site Status RECRUITING

Arthritis and Rheumatic Disease Specialties ( Site 0016)

Aventura, Florida, United States

Site Status RECRUITING

Willow Rheumatology and Wellness, PLLC ( Site 0035)

Willowbrook, Illinois, United States

Site Status RECRUITING

Kansas City Physician Partners ( Site 0027)

Kansas City, Missouri, United States

Site Status RECRUITING

Altoona Center for Clinical Research ( Site 0004)

Duncansville, Pennsylvania, United States

Site Status RECRUITING

Epic Medical Research ( Site 0061)

Red Oak, Texas, United States

Site Status RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 0202)

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

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

Cherkasy, Chernivetska Oblast, Ukraine

Site Status RECRUITING

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

Ukraine, Ivano-Frankivsk Oblast, Ukraine

Site Status RECRUITING

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

Khmelnytskiy, Khmelnytskyi Oblast, Ukraine

Site Status RECRUITING

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

Kyiv, Kyivska Oblast, Ukraine

Site Status RECRUITING

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

Lviv, Lviv Oblast, Ukraine

Site Status RECRUITING

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

Kyiv, , Ukraine

Site Status RECRUITING

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

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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United States Canada Ukraine

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Related Links

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https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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2025-521059-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1318-5807

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-7240-013

Identifier Type: OTHER

Identifier Source: secondary_id

7240-013

Identifier Type: -

Identifier Source: org_study_id