140 Participants NeededMy employer runs this trial

Tulisokibart for Psoriatic Arthritis

Recruiting at 49 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Merck Sharp & Dohme LLC
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tulisokibart to determine if it can reduce symptoms of psoriatic arthritis (PsA), a condition causing joint pain and skin issues. Researchers administer different doses of tulisokibart to participants to identify the most effective dose compared to a placebo (a look-alike with no active medicine). Individuals with active PsA for at least six months who have experienced issues with other treatments might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early findings on its efficacy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that tulisokibart is likely to be safe for humans?

Research shows that tulisokibart has been tested for safety in treating psoriatic arthritis. Earlier studies found that most people tolerated it well, experiencing only mild to moderate side effects. Common side effects included headaches and mild stomach issues. Importantly, these studies did not commonly report serious side effects, suggesting that tulisokibart is generally safe. However, as this is a Phase 2 study, researchers continue to investigate to confirm its safety.12345

Why do researchers think this study treatment might be promising for Psoriatic Arthritis?

Unlike the standard treatments for psoriatic arthritis, such as methotrexate and TNF inhibitors, tulisokibart offers a unique approach by potentially targeting specific pathways involved in the disease. Researchers are excited about tulisokibart because it may act on distinct immune system components related to inflammation and joint damage, providing a new angle for managing the condition. Additionally, tulisokibart's varied dosing regimens, including high, medium, and low doses, allow for flexibility in treatment, which could lead to personalized therapy options and improved patient outcomes.

What evidence suggests that tulisokibart might be an effective treatment for Psoriatic Arthritis?

Studies have shown that tulisokibart can help treat psoriatic arthritis. One study found that 26% of patients who took tulisokibart experienced significant symptom improvement, compared to just 1% of those who took a placebo (a pill with no active medicine). This suggests that tulisokibart might reduce the symptoms of psoriatic arthritis. In this trial, researchers are testing different doses of tulisokibart—high, medium, and low—to determine the most effective one. Early results appear promising, but further research is needed to confirm these findings.13678

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with active psoriatic arthritis who have had symptoms for at least 6 months and either currently have or previously had plaque psoriasis. Participants may not have tried biologic drugs before, or they did but didn't respond well or couldn't tolerate them.

Inclusion Criteria

I have been diagnosed with psoriatic arthritis for at least 6 months.
I have active plaque psoriasis or a history of plaque psoriasis.
I have not used or did not respond well to biologic drugs for my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo-controlled Period

Participants receive either a placebo or one of the study doses of tulisokibart to evaluate efficacy and safety

16 weeks

Main Extension

Participants continue treatment with tulisokibart to further assess long-term efficacy and safety

40 weeks

Optional Extension

Participants may opt into continuation of treatment with tulisokibart for additional long-term assessment

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tulisokibart

Trial Overview

The study is testing different doses of a new medicine called tulisokibart against a placebo (a lookalike with no active drug) to see if it helps reduce symptoms of psoriatic arthritis in adults.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Medium-Dose RegimenExperimental Treatment1 Intervention
Group II: Low-Dose RegimenExperimental Treatment1 Intervention
Group III: High-Dose RegimenExperimental Treatment1 Intervention
Group IV: Placebo RegimenPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

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This review summarises the current PsA treatment landscape and its limitations, and examines emerging therapeutic directions that aim to address ...

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NCT07133633 | A Clinical Study of Tulisokibart (MK-7240) ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

Merck Expands Tulisokibart Clinical Development Program ...

Merck is also currently conducting two Phase 3 studies evaluating the efficacy and safety of tulisokibart in patients with two different types ...