Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)

May 21, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.

Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.

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 PsA 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study consists of a 16-week Placebo-controlled Period and a 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-week Optional Extension.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 3Y2
        • Recruiting
        • Centre de Recherche Musculo-Squelettique ( Site 5202)
        • Contact:
          • Study Coordinator
          • Phone Number: 819-370-1301
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Recruiting
        • Clinica de la Costa S.A.S. ( Site 8301)
        • Contact:
          • Study Coordinator
          • Phone Number: +573017898697
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110221
        • Recruiting
        • Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8306)
        • Contact:
          • Study Coordinator
          • Phone Number: +576014853675
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 8302)
        • Contact:
          • Study Coordinator
          • Phone Number: +576023319090
  • Germany
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03042
        • Recruiting
        • Rheuma-Research Lausitz ( Site 6409)
        • Contact:
          • Study Coordinator
          • Phone Number: +4935575578825
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet ( Site 6400)
        • Contact:
          • Study Coordinator
          • Phone Number: +4923255920
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-065
        • Recruiting
        • MICS Centrum Medyczne Bydgoszcz ( Site 6907)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523401414
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun ( Site 6903)
        • Contact:
          • Study Coordinator
          • Phone Number: +48563004300
    • Lubusz Voivodeship
      • Lublin, Lubusz Voivodeship, Poland, 20-607
        • Recruiting
        • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901)
        • Contact:
          • Study Coordinator
          • Phone Number: +48815243333
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa ( Site 6905)
        • Contact:
          • Study Coordinator
          • Phone Number: +48226291354
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 6906)
        • Contact:
          • Study Coordinator
          • Phone Number: +48226880630
  • Spain
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario ( Site 7102)
        • Contact:
          • Study Coordinator
          • Phone Number: +34981951036
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Recruiting
        • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 7406)
        • Contact:
          • Study Coordinator
          • Phone Number: +380672933485
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21009
        • Recruiting
        • Limited liability company "Medical center Health Clinic" ( Site 7412)
        • Contact:
          • Study Coordinator
          • Phone Number: +38 050 011 53 83
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-443-8400
      • Tucson, Arizona, United States, 85704-1140
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-443-8400
    • California
      • Riverside, California, United States, 92508
        • Recruiting
        • Medvin Clinical Research - Riverside ( Site 5115)
        • Contact:
          • Study Coordinator
          • Phone Number: 951-924-6500
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research - Tujunga ( Site 5113)
        • Contact:
          • Study Coordinator
          • Phone Number: 213-281-5146
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Arthritis and Rheumatic Disease Specialties ( Site 5105)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-652-6676
      • Tampa, Florida, United States, 33614
        • Recruiting
        • International Center for Research ( Site 5124)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-392-1103
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Arthritis and Rheumatism Associates - Rockville ( Site 5127)
        • Contact:
          • Study Coordinator
          • Phone Number: 240-283-2046
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Kansas City Physician Partners ( Site 5119)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-531-0930
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Physician Research Collaboration, LLC ( Site 5102)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-420-1212
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Joint and Muscle Research Institute ( Site 5108)
        • Contact:
          • Study Coordinator
          • Phone Number: 704-248-8577
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research ( Site 5110)
        • Contact:
          • Study Coordinator
          • Phone Number: 814-693-0300
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania ( Site 5134)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-662-2454
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-572-4840
    • Texas
      • Houston, Texas, United States, 77095
        • Recruiting
        • Greater Houston Rheumatology ( Site 5103)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-237-0400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  • Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.
  • Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
  • Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant.

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 PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.
  • Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.
  • 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 of its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Dose Regimen
Participants receive a high dose of tulisokibart.
Drug: Tulisokibart
Subcutaneous administration
Other Names:
  • PRA023
  • MK-7240
Experimental: Medium-Dose Regimen
Participants receive a medium dose of tulisokibart.
Drug: Tulisokibart
Subcutaneous administration
Other Names:
  • PRA023
  • MK-7240
Experimental: Low-Dose Regimen
Participants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
Drug: Tulisokibart
Subcutaneous administration
Other Names:
  • PRA023
  • MK-7240
Placebo Comparator: Placebo Regimen
Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart.
Drug: Placebo
Subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16
Time Frame: Week 16
ACR20 response is defined as a ≥20% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥20% improvement in ≥3 of 5 components: 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) blood values (lower value indicates less inflammation).
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in HAQ-DI Score at Week 16
Time Frame: Baseline and Week 16
The HAQ-DI is a 20-item questionnaire that measures physical function. The questionnaire assesses the degree of difficulty a person has in accomplishing tasks in 8 functional area domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area domain are scored from 0 to 3 (0= without any difficulty; 3= unable to do), with a higher score indicating inability to perform activity. The overall disability score (HAQ-DI) is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3, with the higher value indicating worse disability.
Baseline and Week 16
Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16
Time Frame: Week 16
ACR50 response is defined as a ≥50% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥50% improvement in ≥3 of 5 components: i) HAQ-DI (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) PGA (0= not active to 10= very active; a higher score= more active disease); iii) 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) hsCRP blood values (lower value indicates less inflammation).
Week 16
Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16
Time Frame: Week 16
ACR70 response is defined as a ≥70% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥70% improvement in ≥3 of 5 components: i) HAQ-DI (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) PGA (0= not active to 10= very active; a higher score= more active disease); iii) 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) hsCRP blood values (lower value indicates less inflammation).
Week 16
Number of Participants with ≥1 Adverse Event
Time Frame: Up to approximately Week 142
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately Week 142
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately Week 128
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately Week 128

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

August 13, 2027

Study Completion (Estimated)

January 11, 2030

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7240-015
  • U1111-1318-4301 (Registry Identifier: UTN)
  • 2025-520997-21-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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