Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants with Moderate to Severe Atopic Dermatitis

This research study is looking for adults aged 18 and over who have moderate to severe eczema, also known as atopic dermatitis. The main goal is to test a new medicine, JNJ-95475939, to see how well and how safely it treats eczema symptoms. Participants will be given either the new medicine, a dummy medicine (placebo), or an existing eczema treatment called Dupixent. Researchers will compare these groups to understand if the new medicine helps improve skin redness, itching, and scaling, specifically looking for a 75% improvement in symptoms by week 12. This is a "Phase 2" study, meaning it's still in the early stages of testing in people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen Cilag International

Enrolment target

Start

25 Apr 2025

Moderate to Severe Atopic Dermatitis

What is this study about?

This study is about finding new and better ways to treat moderate to severe atopic dermatitis, which is a long-term skin condition often called eczema. Eczema can cause red, itchy, and inflamed skin, making everyday life uncomfortable. Current treatments help many people, but there's always a need for new options, especially for those whose symptoms are severe or don't respond well to existing medicines.

The main aim of this research is to test a new medicine called JNJ-95475939. This medicine is still being developed, and this study helps researchers understand if it can effectively reduce the symptoms of moderate to severe eczema. They also want to find out the best dose of the medicine to use and to check for any side effects it might have.

To make sure the results are fair and accurate, participants will be randomly assigned to one of three groups: one group will receive the new medicine (JNJ-95475939), another will receive a dummy medicine (called a placebo), and a third group will receive an existing, approved eczema treatment called Dupixent. This allows researchers to compare the new medicine's effects directly against both no active treatment and a known effective treatment.

Key takeaways

This study is testing a new medicine for moderate to severe eczema.
It's open to adults aged 18 and older.
You might receive the new medicine, a dummy medicine, or an existing treatment (Dupixent).
Participation involves regular clinic visits and health checks.
The main goal is to see how well the new medicine improves eczema symptoms.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with moderate to severe atopic dermatitis, which means your eczema is causing significant symptoms and impacting your daily life.

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 a diagnosis of moderate to severe atopic dermatitis (eczema)?
Are you able to attend regular appointments at a clinic?
Are you interested in testing a new potential treatment for eczema?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of three treatment groups. This means you have an equal chance of receiving the new study medicine, a dummy medicine (placebo), or Dupixent. Neither you nor your study doctor will know which treatment you are receiving until the study is over; this is called 'double-blind'.

Throughout the study, you'll have regular visits to the clinic. These visits will involve various checks, such as health assessments, physical examinations, blood tests, and skin evaluations to measure how your eczema is improving or changing. You will take the study medication as directed by the research team. The main part of the study where the treatment effect is measured is up to Week 12, but there will be follow-up appointments after that to monitor your health. The total duration of your involvement in the study will be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new medicine that isn't widely available, and careful monitoring of your health by a medical team. However, there are also potential risks, including side effects from the study medicine or the possibility that the treatment may not help your eczema. Taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
Poland
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Unverified
Germany

Common questions

What is 'atopic dermatitis'?

Atopic dermatitis is the medical name for a common, long-lasting form of eczema that often causes very itchy and dry skin.

What does 'moderate to severe' mean for my eczema?

This means your eczema is having a significant impact on your daily life, causing noticeable symptoms like widespread itching, redness, or skin dryness.

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers see if any improvements are due to the actual medicine or other factors.

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

No, during the study, neither you nor your study doctor will know which treatment you are receiving. This helps make the study results fair and unbiased.

What is 'Phase 2' of a clinical trial?

Phase 2 means the new medicine has already been found safe in a small number of people, and now researchers are testing it on a larger group to see if it works and to find the best dose.