Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis

This research study is investigating a new medication called JNJ-77242113. It's designed for people who have moderate to severe plaque psoriasis, a long-lasting skin condition that causes red, scaly patches. The study aims to find out if this new drug is safe and works better than a dummy treatment (placebo) or an existing treatment called ustekinumab. By comparing these, researchers hope to understand if JNJ-77242113 could be a new option for managing plaque psoriasis. Participants will be closely monitored, and the study will look at how well the treatments clear up their skin and if there are any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

752

Start

15 Apr 2025

Estimated completion

20 Aug 2027

Plaque Psoriasis

What is this study about?

This study is all about finding new and better ways to treat plaque psoriasis. Plaque psoriasis is a common skin condition where the body produces skin cells too quickly, leading to thick, red, scaly patches on the skin. For many people, these patches can be sore, itchy, and affect their daily lives. We call this 'moderate to severe' when it covers a larger area of the body or significantly impacts someone's quality of life.

The main goal of this research is to see how well a new medicine, called JNJ-77242113, works. Researchers want to compare it to a dummy treatment, known as a 'placebo' (which looks like the study drug but contains no active medicine), and to an already approved and used treatment for psoriasis called ustekinumab. By doing this, they can truly understand if JNJ-77242113 is effective in clearing up psoriasis symptoms and if it has any side effects.

Taking part in a study like this helps doctors and scientists learn more about new treatments. Your involvement could help others with psoriasis in the future by providing crucial information on whether this new medication is safe and effective. All participation is voluntary, and your safety and well-being will be a top priority throughout the study.

Key takeaways

This study is testing a new medicine, JNJ-77242113, for moderate to severe plaque psoriasis.
It compares the new medicine against an existing treatment (ustekinumab) and a dummy pill (placebo).
Participation involves regular clinic visits, assessments, and taking study medication.
The study is for people aged 12 and over who meet specific psoriasis criteria.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for volunteers who have **moderate to severe plaque psoriasis**. This means your psoriasis should cover a noticeable amount of your body (at least 10% of your body surface area) and be causing significant discomfort or visible patches. You might also have psoriatic arthritis alongside your skin condition.

To be considered, your doctor would need to have already decided that you might benefit from treatments like light therapy or other body-wide medications for your psoriasis. This study is open to both men and women, aged 12 and above.

However, there are some reasons why you wouldn't be able to join. For instance, if you have other types of psoriasis (like erythrodermic, guttate, or pustular), or if your psoriasis was triggered by certain medications. You also can't participate if you’ve recently had major surgery, are still recovering, or if you have a history of organ transplants (unless it was a corneal transplant over 12 weeks ago). If you're known to be allergic to JNJ-77242113 or ustekinumab, or any of their ingredients, you also wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have moderate to severe plaque psoriasis?
Does my psoriasis cover at least 10% of my body?
Am I already considered for treatments like light therapy or other systemic medications for my psoriasis?
Do I have any allergies to JNJ-77242113, ustekinumab, or similar medicines?
Have I had any major surgery recently (within 8 weeks), or am I planning one soon?
Do I have any other types of psoriasis besides plaque psoriasis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to receive one of the study treatments: the new medicine JNJ-77242113, an existing treatment called ustekinumab, or a dummy treatment (placebo). Neither you nor the study team will know which treatment you are receiving. You'll have regular visits to the clinic where doctors and nurses will closely monitor your skin, assess how your psoriasis is responding, and check for any side effects. You'll likely have physical examinations, blood tests, and other assessments at these visits.

The study involves taking medication, either by injection or another method as prescribed. You'll need to follow the study schedule for your treatments and clinic visits very carefully. The total duration of your participation in the study, including all treatments and follow-up appointments, will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving a new treatment that might help your psoriasis, or close medical monitoring from experts. However, there are also potential risks, including side effects from the study medication, which could range from mild to serious, or the treatment might not work for you. Being in the placebo group means you might not receive an active treatment for a period. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (160)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cahaba Research Inc
Verified postcode
Birmingham, United States
California Dermatology & Clinical Research Institute
Verified postcode
Encinitas, United States
T Joseph Raoof Md Inc
Verified postcode
Encino, United States
First OC Dermatology
Verified postcode
Fountain Valley, United States
Dermatologist Medical Group of North County, Inc.
Verified postcode
Oceanside, United States
NorCal Clinical Research
Verified postcode
Rocklin, United States
Integrative Skin Science and Research
Verified postcode
Sacramento, United States
MedDerm Associates
Verified postcode
San Diego, United States
Southern California Dermatology
Verified postcode
Santa Ana, United States
Olive View-UCLA Education & Research Institute
Verified postcode
Sylmar, United States
University of Conn Health Center
Verified postcode
Farmington, United States
Driven Research LLC
Verified postcode
Coral Gables, United States

Common questions

What is JNJ-77242113?

JNJ-77242113 is a new medicine being tested to see if it can help treat moderate to severe plaque psoriasis.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the real medicine is truly effective.

Can I still get my regular psoriasis treatment if I join?

During the study, you'll receive the study-provided treatment. Your current treatments may need to be adjusted or stopped. This will be fully explained by the study team.

How long will the study last for me?

Your participation in the study, including all treatments and follow-up, will have a specific duration that will be clearly outlined to you during your consent discussion.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you are receiving the new medicine, ustekinumab, or the placebo. This helps ensure fair and accurate results.