CompletedPhase IIInterventional

A study of JNJ-95475939 in the treatment of participants with moderate to severe atopic dermatitis

This study is looking into a new medicine called JNJ-95475939 for people with moderate to severe eczema, also known as atopic dermatitis. Eczema causes itchy, dry, and red skin. The new medicine aims to calm down the body's overactive immune response that causes these symptoms. Researchers want to compare this new drug to a dummy treatment (placebo) and an existing eczema medication called dupilumab, to see how well it works and if it's safe. It's a Phase II trial, meaning it's still in the earlier stages of testing. Adults aged 18 and over who have moderate to severe eczema may be able to take part.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Janssen-Cilag International NV

Enrolment target

240

Start

26 Feb 2025

Estimated completion

22 Sep 2025

Atopic dermatitis (AD)

What is this study about?

This study is investigating a new medication called JNJ-95475939, which is being tested for people who have moderate to severe eczema, medically known as atopic dermatitis. Eczema is a very common skin condition that causes skin to become itchy, dry, and red. It can be quite uncomfortable and sometimes leads to a lot of itching and scratching, which can make the skin worse.

We know that eczema often happens because the body's immune system is a bit overactive, leading to inflammation in the skin. This new medicine, JNJ-95475939, is designed to block certain signals in the body that cause this inflammation and the constant itching. By doing so, it's hoped that the medicine could help improve eczema symptoms.

The main goal of this study is to find out how effective JNJ-95475939 is and if it has any side effects, especially when compared to a dummy treatment (placebo) and another medicine already used for eczema called dupilumab. The researchers hope that the results will help them understand if this new medicine could be a good treatment option for people with eczema in the future.

Key takeaways

Tests a new medicine (JNJ-95475939) for moderate to severe eczema.
Compares the new medicine to a dummy treatment and an existing eczema drug.
Involves adults (18+) with active eczema that hasn't responded well to other treatments.
Participation lasts up to 41 weeks, including screening, treatment, and follow-up.
Potential benefits include improved eczema and helping future patients.
Possible risks include side effects, some of which are not yet fully known.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older, who have moderate to severe eczema. Your eczema needs to have started at least a year ago and be affecting a noticeable part of your body (at least 10%). Also, your skin condition will be checked using specific scores to make sure it's moderate to severe at the start of the study, and your itching needs to be at a certain level.

You might be suitable if previous treatments, like creams or other medications, haven't worked well enough for you. You also need to be regularly using moisturiser.

However, you won't be able to join if you've previously had a poor response or serious side effects to similar types of eczema medications (like dupilumab, lebrikizumab, or tralokinumab). Pregnant or breastfeeding individuals, or those planning to become pregnant, cannot take part. If you have other significant skin infections or serious underlying health conditions, you might also not 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.

Are you 18 years old or older?
Have you been diagnosed with eczema (atopic dermatitis) for at least a year?
Is your eczema currently moderate to severe and affecting at least 10% of your body?
Are you regularly using moisturiser at least once a day?
Have other eczema treatments (creams or medications) not worked well enough for you?
Are you not pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for a total of up to 41 weeks. There are three main parts:

First, there's a 'screening period' of up to 5 weeks. During this time, you'll have checks to see if you're suitable for the study. If you are, you'll move to the next stage.

Then comes the 'treatment period' which lasts up to 24 weeks. You'll be placed into one of five groups by chance, like drawing numbers from a hat. This means you might receive the new medicine (JNJ-95475939) in one of three different doses, an existing medicine (dupilumab), or a dummy treatment (placebo) for the first 12 weeks, before switching to the new medicine for the remaining 12 weeks. All study medicines are given as an injection just under the skin.

Finally, there's a 'follow-up period' of up to 12 weeks. During this time, you won't receive the study medicine, but the team will monitor your health. Throughout the study, you'll have regular checks like physical exams, weight measurements, blood pressure, heart checks (ECG), blood tests, and pregnancy tests (if applicable) to make sure you're safe and to track any changes.

Potential risks and benefits

There's no guarantee that participating will directly benefit you, as this is a research study and the new medicine is still being tested. However, based on what we know, JNJ-95475939 might improve your eczema. If you're in the placebo group initially, you won't get the active study drug for the first 12 weeks. Even without the study drug, you might feel better simply because you're having regular health checks. Your involvement could also help other people with eczema in the future by increasing our understanding of the condition and potential treatments. While regular checks are in place to minimise risks, all medications carry potential side effects. Known potential side effects for this type of medication include allergic reactions, skin reactions at the injection site, and eye inflammation or infection. It's important to know that not all possible side effects are known yet, and some could be severe or even life-threatening. The study doctor will keep you informed of any new safety information, and you're free to withdraw from the study at any time.

Locations (13)

Guys and St Thomas NHS Foundation Trust
City only
London, England
Northwick Park Hospital
Approximate
Harrow, England
Salford Royal NHS Foundation Trust
City only
Salford, England
The Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
City only
King's Lynn, England
Royal London Hospital
Approximate
London, England
INAER - Investigación en Alergias y Enfermedades Respiratorias
City only
Buenos Aires, Argentina
CETI - Centro de Estudos em Terapias Inovadoras Ltda
City only
Curitiba, Brazil
Dermatology Research Institute Inc
City only
Calgary, Canada
Studienzentrum Dr Schwarz Germany
City only
Langenau, Germany
Nomura Dermatology Clinic
City only
Yokohama, Japan
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Unverified
Krakow, Poland
GRUPO DERMATOLOGICO Y ESTETICO PEDRO JAEN
Unverified
Madrid, Spain

Common questions

What is atopic dermatitis (eczema)?

It's a common skin condition that makes your skin very itchy, dry, and red. It's often linked to the immune system being overactive.

What does 'Phase II' mean for a trial?

Phase II means the new medicine is being tested in a small group of people to see if it works and to check for potential side effects. It's still an early stage of testing.

Will I know which treatment I'm getting?

No, you won't know directly. You'll be randomly assigned to one of five groups, which could be the new medicine, an existing medicine, or a dummy treatment (placebo) at first. This helps ensure the study results are fair.

Do I have to pay to be in the study?

No, there are no costs for participating. The study drug and tests are paid for, and you'll receive reasonable reimbursement for travel and other study-related expenses.

Can I leave the study at any time?

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

How to find out more

. Medical Information and Product Information Enquiry

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

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