NCT07486960

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
44mo left

Started Apr 2026

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Jan 2030

First Submitted

Initial submission to the registry

March 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2027

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 19, 2026

Last Update Submit

April 30, 2026

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at 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 Outcomes (5)

  • Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16

    Week 16

  • Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16

    Week 16

  • Change from Baseline in HAQ-DI Score at Week 16

    Baseline and Week 16

  • Number of Participants with ≥1 Adverse Event

    Up to approximately Week 142

  • Number of Participants Who Discontinue Study Intervention Due to an AE

    Up to approximately Week 128

Study Arms (4)

High-Dose Regimen

EXPERIMENTAL

Participants receive a high dose of tulisokibart.

Drug: Tulisokibart

Medium-Dose Regimen

EXPERIMENTAL

Participants receive a medium dose of tulisokibart.

Drug: Tulisokibart

Low-Dose Regimen

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 Regimen

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

TulisokibartDRUG

Subcutaneous administration

Also known as: MK-7240, PRA023
High-Dose RegimenLow-Dose RegimenMedium-Dose Regimen
PlaceboDRUG

Subcutaneous administration

Placebo Regimen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)

Tucson, Arizona, 85704-1140, United States

RECRUITING

Arthritis and Rheumatism Associates - Rockville ( Site 5127)

Rockville, Maryland, 20850, United States

RECRUITING

Altoona Center for Clinical Research ( Site 5110)

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)

Summerville, South Carolina, 29486, United States

RECRUITING

Greater Houston Rheumatology ( Site 5103)

Houston, Texas, 77095, United States

RECRUITING

Centre de Recherche Musculo-Squelettique ( Site 5202)

Trois-Rivières, Quebec, G9A 3Y2, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839Trialsites@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

March 19, 2026

First Posted

March 23, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

August 13, 2027

Study Completion (Estimated)

January 11, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

More information

Locations

US(5)CA(1)