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

Purpose

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.

Condition

  • Psoriatic Arthritis

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High-Dose Regimen
Participants receive a high dose of tulisokibart.
  • Drug: Tulisokibart
    Subcutaneous administration
    Other names:
    • MK-7240
    • PRA023
Experimental
Medium-Dose Regimen
Participants receive a medium dose of tulisokibart.
  • Drug: Tulisokibart
    Subcutaneous administration
    Other names:
    • MK-7240
    • PRA023
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:
    • MK-7240
    • PRA023
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

Recruiting Locations

Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)
Tucson, Arizona 85704-1140
Contact:
Study Coordinator
480-443-8400

Arthritis and Rheumatism Associates - Rockville ( Site 5127)
Rockville, Maryland 20850
Contact:
Study Coordinator
240-283-2046

Altoona Center for Clinical Research ( Site 5110)
Duncansville, Pennsylvania 16635
Contact:
Study Coordinator
814-693-0300

Greater Houston Rheumatology ( Site 5103)
Houston, Texas 77095
Contact:
Study Coordinator
832-237-0400

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

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.