Active not recruitingPHASE3INTERVENTIONAL

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

This research study is investigating a new medication, JNJ-77242113, for people aged 12 and older who have moderate to severe plaque psoriasis. Plaque psoriasis causes thick, scaly patches on the skin. The main goal is to find out if this new treatment is effective in helping to clear up these skin patches. Some participants will receive the new medicine, while others will receive a placebo (a dummy treatment) to compare how well it works. This is a Phase 3 study, which means it’s one of the final stages of testing before a new treatment might be approved for wider use. By taking part, you could contribute to understanding if this new medicine could offer a better way to manage psoriasis for many people.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

684

Start

12 Oct 2023

Estimated completion

06 Apr 2027

Plaque Psoriasis

What is this study about?

Many people live with plaque psoriasis, a skin condition that can cause red, flaky, and sometimes itchy patches on the skin. For those with moderate to severe plaque psoriasis, finding effective treatments that significantly improve their quality of life is very important. This study is testing a new medication, JNJ-77242113, to see if it can help reduce these symptoms.

We know that psoriasis can impact daily life, and researchers are constantly looking for new and better ways to manage it. This particular study is designed to carefully measure how well JNJ-77242113 works compared to a placebo. A placebo looks like the real medicine but contains no active ingredients. This comparison is crucial for understanding the true effects of the new treatment.

By taking part in this study, you would be helping medical science learn more about JNJ-77242113. Your contribution could help determine if this treatment could eventually become an option for many others living with plaque psoriasis in the future. The trial is open to both teenagers (from 12 years old) and adults, ensuring that potential benefits across different age groups are understood.

Key takeaways

This study tests a new psoriasis treatment, JNJ-77242113.
It's for moderate to severe plaque psoriasis in ages 12 and up.
Compares the new drug against a placebo to see if it works.
Involves regular clinic visits and health checks.
Your participation could help others with psoriasis.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to have been diagnosed with plaque psoriasis, with or without psoriatic arthritis, for at least 6 months. Your psoriasis should cover 10% or more of your body, and your skin symptoms must be considered moderate to severe by the doctors. This usually means significant areas of scaly patches on your skin.

You also need to be someone who would normally be considered for treatments like light therapy or other medications that affect your whole body for your psoriasis. If you are female and could become pregnant, you will need to have negative pregnancy tests before starting the study.

There are also some reasons you might not be able to join. For example, if you have other types of psoriasis (like guttate or pustular), if your psoriasis was triggered by certain medications, or if you have serious uncontrolled health problems affecting your kidneys, liver, heart, or other major organs. Also, if you have known allergies to the study medicine or have had major surgery recently or have one planned during the study, you would not be able to take part.

Quick self-check

I have plaque psoriasis, diagnosed at least 6 months ago.
My psoriasis covers a significant area of my body (more than 10%).
My doctor considers my psoriasis moderate to severe.
I might normally be considered for light therapy or other systemic psoriasis treatments.
I do not have other serious uncontrolled medical conditions.
If I am female and can get pregnant, I am willing to have pregnancy tests.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the new study medicine, JNJ-77242113, or a placebo. You won't know which one you are receiving. The study involves regular visits to the clinic where doctors and nurses will monitor your health and how your skin is responding. They will take measurements of your skin, ask about your symptoms, and carry out various health checks, such as blood tests.

These visits will happen over a period of time, and you'll receive the study medication regularly as prescribed. It's important to attend all appointments so the research team can gather all necessary information. The exact number of visits, assessments, and the total length of your participation will be explained in detail by the study team, but generally these trials run for many months to ensure the treatment's full effects are understood.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as receiving a new investigational treatment for your psoriasis and having your health closely monitored by medical professionals. However, there are also potential risks, including side effects from the medication or the possibility that the treatment may not improve your psoriasis. You will be fully informed of all known potential risks before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (170)

Medical Dermatology Specialists
Phoenix, United States
Johnson Dermatology
Fort Smith, United States
First OC Dermatology
Fountain Valley, United States
Center for Dermatology Clinical Research
Fremont, United States
Integrative Skin Science and Research
Sacramento, United States
Rady Childrens Hospital San Diego
San Diego, United States
Southern California Dermatology
Santa Ana, United States
Clinical Science Institute
Santa Monica, United States
Bioclinical Research Alliance Inc.
Miami, United States
Ziaderm Research LLC
North Miami Beach, United States
Forcare Clinical Research Inc
Tampa, United States
Skin Care Physicians of Georgia
Macon, United States

+158 more sites — see the official record for the full list.

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition where skin cells grow too quickly, causing thick, red, scaly patches that can be itchy or painful.

What is JNJ-77242113?

JNJ-77242113 is a new medication being tested in this study to see if it can effectively treat moderate to severe plaque psoriasis.

What is a Phase 3 study?

A Phase 3 study means it's one of the final stages of testing before a new medicine might be considered for wider use. It involves many people to confirm its effectiveness and safety.

Will I know if I'm getting the real medicine or a placebo?

In this type of study, neither you nor your study doctor will know whether you are receiving the active medicine or a placebo. This helps ensure the study results are fair and accurate.

Can teenagers join this study?

Yes, this study is open to both adults and teenagers aged 12 years and older who meet the other study requirements.