CompletedPhase IIIInterventional

A study comparing JNJ-77242113 and ustekinumab in adult participants with moderate to severe plaque psoriasis

This study is testing a new medication called JNJ-77242113 for adults with moderate to severe plaque psoriasis. Psoriasis causes red, scaly, and often itchy patches on the skin. The new drug works by blocking a specific protein (IL-23) that causes inflammation, hoping to improve skin symptoms. Researchers want to see how effective JNJ-77242113 is compared to a dummy treatment (placebo) and an already approved medication called Stelara (ustekinumab). Participants will be placed into groups by chance and receive either the new drug, Stelara, or a placebo for different periods, followed by the new drug. The study will track how well the treatments work and any side effects over about two years. If you're an adult with moderate to severe psoriasis, especially if other treatments haven't worked well, you might be eligible.

At a glance

Status

Completed

Phase

Phase III

Sponsor

Janssen-Cilag International NV

Enrolment target

675

Start

15 Apr 2025

Estimated completion

05 Nov 2025

Plaque psoriasis

What is this study about?

This study is looking into a new medication called JNJ-77242113 for people who have moderate to severe plaque psoriasis. Psoriasis is a skin condition that leads to red, scaly, sometimes itchy, and painful patches on the skin. This new drug works by calming down inflammation in the body. It does this by blocking a specific protein, called IL-23, which is known to play a big part in causing psoriasis symptoms. By stopping this protein from working, the hope is to reduce the inflammation and improve the skin condition.

The main goal of this study is to find out how well JNJ-77242113 works compared to a 'dummy' treatment (placebo) which contains no active medicine, and also how it compares to an existing, approved treatment for psoriasis called Stelara (ustekinumab). Stelara also works by targeting specific proteins involved in inflammation. The researchers want to carefully measure if JNJ-77242113 can effectively clear up psoriasis plaques and make life better for those living with the condition.

Taking part in a study like this helps us learn more about new potential treatments. Even if this specific drug doesn't directly help everyone who takes it, the information gathered is really important. It helps doctors understand more about psoriasis and develop better ways to treat it in the future, potentially benefiting many others.

Key takeaways

This study is for adults with moderate to severe plaque psoriasis.
It compares a new drug (JNJ-77242113) with an existing one (Stelara) and a dummy treatment (placebo).
Participation involves regular clinic visits, medical tests, and taking study medication.
The study lasts for about two years, including check-ups for side effects.
There's no cost to you, and travel expenses are covered.
You can leave the study at any time without affecting your usual medical care.

Who may be eligible?

This study is looking for adults aged 18 and over who have moderate to severe plaque psoriasis. This means your psoriasis affects at least 10% of your body and is severe enough that your doctor has considered treatments like light therapy or other medications that affect your whole body.

You should have had your plaque psoriasis for at least 26 weeks. The study is specifically for plaque psoriasis, so if you have other types like erythrodermic or pustular psoriasis, you would not be able to join. Also, if your psoriasis was triggered by a specific medication you're currently taking, you wouldn't be eligible.

It's important that you don't have any known allergies to the study drugs (JNJ-77242113 or ustekinumab) or their ingredients. If you've had major surgery recently, or have an organ transplant (except for a corneal transplant more than 12 weeks ago), you might not be able to participate. Your study doctor will thoroughly check if this study is right 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?
Do you have moderate to severe plaque psoriasis?
Does your psoriasis cover at least 10% of your body?
Have you had plaque psoriasis for at least 6 months?
Are you generally healthy enough to participate in a clinical study?
Are you not allergic to JNJ-77242113 or ustekinumab (Stelara)?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several stages over about two years. First, there's a 'screening period' of up to 5 weeks to confirm you're suitable. Then, for the 'treatment period', you'll be put into one of three groups by chance (like drawing straws – neither you nor the doctor chooses).

• One group will receive the new medicine, JNJ-77242113, for two years, along with dummy injections matching Stelara for the first few weeks. • Another group will receive dummy injections of JNJ-77242113 for 16 weeks, then switch to the new medicine JNJ-77242113 for the rest of the two years, plus dummy injections matching Stelara at the start. • A third group will receive Stelara for the first 16 weeks, then switch to JNJ-77242113 for the rest of the two years, with dummy injections matching JNJ-77242113 for the first few weeks.

Throughout the study, you'll have regular check-ups, which include blood tests, heart readings (ECGs), physical exams, and questions about how you're feeling. These are to monitor your health and any side effects. After your treatment finishes, there will be a safety follow-up period of up to 4 weeks. All side effects will be tracked until the very end of the study, which is about 113 weeks in total.

Potential risks and benefits

There's no guarantee that participating in this study will directly benefit you. The new drug, JNJ-77242113, is still being tested, so we don't yet know for sure if it will help your psoriasis. However, by taking part, you'll receive regular medical checks and monitoring, which can be beneficial independently of the study drugs. Your participation will also help us learn more about psoriasis and potentially lead to better treatments for others in the future. Like all medications, the drugs used in this study (JNJ-77242113 and Stelara) can cause side effects. These can range from mild to serious, and in very rare cases, can be life-threatening. Possible side effects for JNJ-77242113 include strong reactions from your immune system or developing antibodies that might make the drug less effective, and infections. Stelara has known risks including infections, allergies, certain cancers, heart problems, and you'd need to be careful with live vaccines or other immune-suppressing medicines. Not all possible side effects of the new drug are known yet, but the study team will tell you immediately about any new risks identified. Your safety is a priority, and the study team will frequently review you for any side effects and provide appropriate medical care. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (9)

Pinderfields Hospital
Approximate
Wakefield, United Kingdom
Russells Hall Hospital
Approximate
Dudley, United Kingdom
Queen Elizabeth Hospital Kings Lynn
Approximate
King's Lynn, United Kingdom
Salford Royal NHS Foundation Trust
City only
Salford, United Kingdom
Southampton General Hospital
Approximate
Southampton, United Kingdom
Guys and St Thomas NHS Foundation Trust
City only
London, United Kingdom
Royal Berkshire Hospital
Approximate
Reading, United Kingdom
Northwick Park Hospital
Approximate
Harrow, United Kingdom
Russells Hall Hospital
Approximate
Dudley, United Kingdom

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition that causes patches of thick, red skin covered with silvery scales. These patches can be itchy and sometimes painful.

What is JNJ-77242113?

JNJ-77242113 is a new medicine being tested for plaque psoriasis. It works by blocking a protein (IL-23) in your body that causes inflammation, aiming to reduce psoriasis symptoms.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to see if the actual medicine works better than no treatment at all.

Will I have to pay to join the study?

No, you won't have to pay anything to take part. The study drugs and tests are covered, and you'll get help with travel costs.

How long will the study last if I join?

The study involves a screening period, then treatment and follow-up, lasting for about two years in total, with checks continuing for up to 113 weeks.

How to find out more

Medical Information and Product Information Enquiry -

medinfo@its.jnj.com +44 (0)800 731 8450 / 10494 567 444 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.