Active not recruitingPHASE3INTERVENTIONAL

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

This important study is investigating a new medication called JNJ-77242113 for adults who have moderate to severe plaque psoriasis. The main goal is to understand how effective and safe this new medicine is. Researchers will compare JNJ-77242113 with a placebo (a treatment with no active medicine) and with another existing psoriasis medicine called deucravacitinib. By doing this, they hope to find out if JNJ-77242113 could be a helpful new option for managing plaque psoriasis, improving symptoms, and improving quality of life for those affected. This is a Phase 3 study, which means it’s one of the final steps before a medicine might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

774

Start

01 Feb 2024

Estimated completion

01 Jun 2027

Plaque Psoriasis

What is this study about?

Plaque psoriasis is a long-lasting skin condition that causes red, scaly patches on your skin. These patches can be itchy, painful, and sometimes disfiguring. It happens when your body's immune system mistakenly attacks healthy skin cells, causing them to grow too quickly. Some people with psoriasis also develop a type of arthritis called psoriatic arthritis, which affects the joints.

This research study is about testing a new potential medicine, called JNJ-77242113, for people who have moderate to severe plaque psoriasis. 'Moderate to severe' means your psoriasis covers a significant area of your body and has a noticeable impact on your daily life. The study aims to see how well this new medicine works compared to a 'dummy' treatment (placebo) and an existing medicine called deucravacitinib.

Finding new and effective treatments is really important for people living with psoriasis. Medications can help to clear up skin patches, reduce itching and discomfort, and improve overall quality of life. By taking part in studies like this, volunteers help scientists understand if new medicines are safe and can make a real difference in managing the condition.

Key takeaways

This study is testing a new medicine (JNJ-77242113) for moderate to severe plaque psoriasis.
It compares the new medicine against a dummy treatment (placebo) and an existing treatment (deucravacitinib).
You must be an adult with chronic plaque psoriasis affecting a significant body area to be considered.
Participation involves regular clinic visits for checks, blood tests, and monitoring.
You won't know which treatment you receive; this is to ensure fair results.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have been diagnosed with plaque psoriasis for at least six months. Your psoriasis should be affecting a noticeable amount of your body, usually at least 10% of your skin, and be severe enough that your doctor would consider treatments like light therapy or other strong medicines.

There are also some reasons why you might not be able to join. For example, if you have other types of psoriasis that aren't plaque psoriasis, or if your psoriasis was caused by a specific medicine you're taking. You also can't participate if you have serious ongoing problems with your kidneys, liver, heart, or other major body systems, or if you've had a big operation recently (within the last 8 weeks) or have one planned. If you have known allergies to any of the study medicines or their ingredients, you wouldn't be able to take part either.

The research team will review your medical history and do some tests to make sure the study is a safe and suitable option for you.

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.

Are you 18 years old or older?
Have you had plaque psoriasis for at least 6 months?
Does your psoriasis cover a noticeable part of your body (at least 10%)?
Would your doctor consider light therapy or other strong medicines for your psoriasis?
Do you have any serious ongoing health problems with your kidneys, liver, or heart?
Have you had a major surgery in the last 8 weeks, or do you have one planned soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given one of the study treatments – either JNJ-77242113, the existing medicine deucravacitinib, or a placebo (which looks like the study medicine but has no active ingredients). Which treatment you receive will be decided by chance, like flipping a coin. You won't know which one you're getting, and neither will the study team.

Your participation will involve regular visits to the study clinic where the doctors and nurses will monitor your health, check your psoriasis, and ask you about any symptoms or side effects you might be having. These visits will include physical examinations, blood tests, and other assessments to track your progress. The total length of your participation in the study will be explained to you by the study team, including how long you'll be taking the medicine and how long the follow-up period will be.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving a new medicine before it's widely available or having closer monitoring of your health. However, there are also potential risks; the new medicine might have side effects that are not yet fully known, or it might not work for you. The placebo treatment also means you might not receive an active medicine for a period. You will be closely watched for any side effects, and all possible risks will be explained to you. Remember, joining this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (164)

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

Medical Dermatology Specialists
Verified postcode
Phoenix, United States
Center for Dermatology and Plastic Surgery
Verified postcode
Scottsdale, United States
Johnson Dermatology
Verified postcode
Fort Smith, United States
First OC Dermatology
Verified postcode
Fountain Valley, United States
Center for Dermatology Clinical Research
Verified postcode
Fremont, United States
Integrative Skin Science and Research
Verified postcode
Sacramento, United States
Southern California Dermatology
Verified postcode
Santa Ana, United States
Clinical Science Institute
Verified postcode
Santa Monica, United States
Driven Research LLC
Verified postcode
Coral Gables, United States
Ziaderm Research LLC
Verified postcode
North Miami Beach, United States
Renstar Medical Research
Verified postcode
Ocala, United States
Forcare Clinical Research Inc
Verified postcode
Tampa, United States

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition where skin cells grow too quickly, leading to red, scaly patches on the skin that can be itchy or painful.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare how well the actual medicine works.

Will I know which treatment I am getting?

No, this study is 'blinded,' meaning you, your doctor, and the study team won't know if you're receiving the new medicine, the existing medicine, or the placebo. This helps make the study results fair.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

What is a Phase 3 study?

Phase 3 is one of the final stages of testing a new medicine. It involves a larger number of patients and aims to confirm the medicine's effectiveness, monitor side effects, and compare it with existing treatments.