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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: Tulisokibart; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07486960

U1111-1318-4301 (Registry Identifier)

2025-520997-21-00 (Registry Identifier)

7240-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 4 patient groups, including a placebo group

High-Dose Regimen

Experimental group

Description:

Participants receive a high dose of tulisokibart.

Treatment:

Drug: Tulisokibart

Medium-Dose Regimen

Experimental group

Description:

Participants receive a medium dose of tulisokibart.

Treatment:

Drug: Tulisokibart

Low-Dose Regimen

Experimental group

Description:

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

Treatment:

Drug: Tulisokibart

Placebo Regimen

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo