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Study on the Effectiveness and Safety of JNJ-95475939 and Dupilumab for Treating Moderate to Severe Atopic Dermatitis in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for people with moderate to severe atopic dermatitis, a common skin condition that causes red, itchy, and inflamed skin. The study will test a new medication called JNJ-95475939, which is given as a solution for injection under the skin. Another medication, Dupixent, which is already used to treat atopic dermatitis, will also be part of the study to compare its effects with the new treatment. Additionally, some participants will receive a placebo.

The purpose of the study is to evaluate how well JNJ-95475939 works in reducing the symptoms of atopic dermatitis compared to a placebo. Participants in the study will be randomly assigned to receive either the new medication, Dupixent, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will take place over a period of 24 weeks, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any side effects.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to assess the effectiveness of the treatments. The main goal is to see if the new medication can help improve the skin condition and provide relief from the symptoms of atopic dermatitis. This study is an important step in finding new and effective treatments for people living with this challenging skin condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study criteria.
You will be asked to provide consent to participate in the study. This involves understanding the study's purpose, procedures, and potential risks and benefits.
Step 2
Randomization
After the initial visit, you will be randomly assigned to one of the study groups. This means you may receive either the study medication JNJ-95475939, an active comparator called Dupixent, or a placebo.
The assignment is random, similar to flipping a coin, and neither you nor the study team will know which group you are in. This is called a double-blind study.
Step 3
Medication administration
If you are assigned to receive JNJ-95475939, you will receive it as a solution for injection under the skin (subcutaneous use).
If you are assigned to receive Dupixent, you will receive a 300 mg solution for injection in a pre-filled syringe, also administered under the skin.
The frequency and dosage of the medication will be determined by the study protocol and communicated to you by the study team.
Step 4
Follow-up visits
Throughout the study, you will attend regular follow-up visits. These visits are important for monitoring your health and the effects of the medication.
During these visits, you may undergo physical examinations, provide blood samples, and complete questionnaires about your symptoms and overall health.
Step 5
End of study
The study will conclude after a specified period, which is estimated to be around 12 weeks from the start of your participation.
At the end of the study, you will have a final visit where your health will be assessed, and you will have the opportunity to discuss your experience with the study team.

Who can join the trial?

13 criteria

Must be at least 18 years old or the legal age of consent in the area where the study is conducted.
Must be generally healthy based on a physical exam, medical history, vital signs, and heart test (ECG) at the start of the study. Any health issues should be related to the condition being studied.
Must have chronic atopic dermatitis (AD) with symptoms starting at least 1 year before joining the study.
Must have a EASI score of 16 or higher at the start of the study. EASI is a tool used to measure the severity of eczema.
Must have a vIGA-AD score of 3 or higher at the start of the study. This score helps assess the severity of the skin condition.
Must have at least 10% of the body affected by AD at the start of the study.
Must have a baseline PP-NRS average score of 4 or higher. This score measures itchiness.
Must have a history of not responding well to topical treatments or systemic therapies for AD.
Must have used a moisturizer at least once daily for at least 7 days before starting the study.
If female, must agree not to be pregnant, breastfeeding, or planning to become pregnant during the study and for 90 days after the last dose of the study medication.
If female and able to have children, must have a negative pregnancy test before starting the study and agree to use effective birth control methods.
If male, must agree not to father a child or donate sperm during the study and for 90 days after the last dose of the study medication.
If male and not had a vasectomy, must agree to use a barrier method of birth control, like a condom, during the study and for 90 days after the last dose of the study medication.

Who cannot join the trial?

10 criteria

Participants cannot have any other skin conditions that might interfere with the study.
Participants should not have a history of severe allergic reactions to any medications.
Participants must not be using any other treatments for atopic dermatitis during the study.
Participants cannot have any serious health conditions that might affect their safety or the study results.
Participants should not be pregnant or planning to become pregnant during the study.
Participants must not have participated in another clinical trial within the last 30 days.
Participants should not have any active infections that require treatment.
Participants must not have a history of drug or alcohol abuse within the past year.
Participants should not have received any live vaccines within 4 weeks before the study starts.
Participants must not have any known immune system disorders.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Verified
Gdansk, Poland
Studienzentrum Dr. Beate Schwarz
Responsive
Langenau, Germany

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Investigated drugs

JNJ-95475939 is a new medication being tested to see if it can help people with moderate to severe atopic dermatitis, which is a type of skin condition that causes red, itchy, and inflamed skin. This medication is being studied to understand how well it works in reducing the symptoms of this skin condition and to ensure it is safe for people to use. Participants in the trial will receive this medication to see if it can improve their skin condition compared to those who do not receive it.

Dupilumab

What is already known about the treatment

JNJ-95475939 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis, a skin condition characterized by itchy and inflamed skin. The drug is in the experimental phase and is not yet widely recognized in medical literature as a standard treatment. It works by targeting specific pathways in the immune system to reduce inflammation and alleviate symptoms. JNJ-95475939 is classified as an immunomodulatory agent, which means it helps regulate the immune system's response.

Investigated diseases

Atopic Dermatitis – Atopic Dermatitis is a chronic inflammatory skin condition characterized by itchy, red, and swollen skin. It often begins in childhood and can persist into adulthood. The skin may become dry, cracked, and prone to infections due to frequent scratching. Flare-ups can occur, leading to more intense symptoms. The condition is associated with a malfunction in the skin barrier and immune system. Environmental factors, allergens, and stress can exacerbate the symptoms.