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Study on the Effectiveness and Safety of BP1.7881 for Adults with Moderate-to-Severe Atopic Dermatitis

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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 atopic dermatitis, a condition that causes the skin to become red, itchy, and inflamed. The trial will evaluate a new treatment called BP1.7881, which is a film-coated tablet taken by mouth. BP1.7881 is a type of medication known as a dual histamine H1 and H4 receptor antagonist, which means it works by blocking certain substances in the body that can cause allergic reactions and inflammation.

The purpose of the study is to assess the safety and effectiveness of BP1.7881 in adults with moderate-to-severe atopic dermatitis. Participants in the trial will be randomly assigned to receive either the BP1.7881 tablet or a matching placebo tablet, which looks like the real medication but does not contain the active ingredient. The study will last for 12 weeks, during which participants will take the tablets and attend regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the trial, researchers will be looking at various outcomes, such as changes in the severity of the skin condition and the level of itching experienced by participants. The goal is to determine whether BP1.7881 can provide significant relief from the symptoms of atopic dermatitis compared to the placebo. This study is important for understanding how well BP1.7881 works and ensuring it is safe for people with this skin condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and start of treatment
Upon joining the trial, you will be randomly assigned to one of two groups. One group will receive the investigational medication BP1.7881, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.
You will take the assigned tablet orally as a film-coated tablet once daily for a duration of 12 weeks.
Step 2
Regular check-ups and assessments
Throughout the 12-week period, you will attend regular check-ups. These visits are important to monitor your health and the effects of the treatment.
During these visits, your skin condition will be assessed using the Eczema Area Severity Index (EASI) and the Investigator's Global Assessment (IGA). These are tools used to measure the severity of your atopic dermatitis.
Step 3
Completion of treatment
At the end of the 12-week treatment period, you will have a final assessment to evaluate the changes in your skin condition.
The primary goal is to measure the mean change in your EASI score from the start to the end of the trial. Secondary goals include assessing improvements in your IGA score and the intensity of itchiness using the Pruritus Numerical Rating Scale (NRS).
Step 4
Post-treatment follow-up
After completing the treatment, you may be asked to attend follow-up visits to monitor any lasting effects of the treatment.
Male participants are required to continue using reliable contraception methods for 90 days after the last dose of the study drug.

Who can join the trial?

11 criteria

Provide written informed consent before any trial-related procedures. This means you agree to participate after being informed about the study.
Be a male or female who is 18 years old or older.
Have a diagnosis of chronic atopic dermatitis that has been present for at least 12 months before joining the study.
Have moderate to severe atopic dermatitis, which is measured by specific scores used by doctors to assess the severity of eczema.
Have an average itch intensity score of 4 or more on a scale of 0 to 10, but less than 10.
Have a history of not responding well to topical medications (creams or ointments applied to the skin) within the last 6 months, or be unable to use them due to side effects or safety concerns.
If using a specific skin moisturizer or similar products, keep using the same amount for at least 10 days before starting the study and continue during the study.
Be willing to follow all study requirements and procedures, such as filling out questionnaires, taking the study medication as instructed, not using certain other medications, and having a smartphone with internet access.
Male patients must have had a vasectomy or agree to use reliable birth control methods, like condoms, or practice total abstinence during the study and for 90 days after the last dose of the study drug.
Female patients must be post-menopausal (no periods for at least 12 months) or, if they can become pregnant, use a highly effective birth control method during the study and for one month after stopping the study medication.
If required, be insured by the appropriate national health insurance system.

Who cannot join the trial?

9 criteria

Patients who have a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
Patients who are currently participating in another clinical trial are not eligible.
Patients with other skin conditions that might interfere with the study results cannot take part.
Patients who have used certain medications that might affect the study results within a specific time frame before the study starts are excluded.
Patients with a history of certain chronic diseases that might interfere with the study are not eligible.
Pregnant or breastfeeding women cannot participate in the study.
Patients who have had a recent major surgery are not eligible.
Patients with a history of drug or alcohol abuse within a certain period before the study cannot participate.
Patients who are unable to comply with the study procedures and visits are excluded.

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Verified sites

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

Centre Hospitalier Lyon Sud
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Pierre Benite, France
Centrum Badan Klinicznych Pi-House Sp. z o.o.
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Gdansk, Poland
Goethe University Frankfurt
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Frankfurt, Germany

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Investigated drugs

BP1.7881 is a medication being tested for its ability to 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 taken by mouth and is being studied to see if it can reduce the symptoms of atopic dermatitis and improve the quality of life for those who have it. The trial is also looking at how safe the medication is for patients to use over a period of 12 weeks.

Bp1.7881A

What is already known about the treatment

BP1.7881 – BP1.7881 is an oral medication currently being studied for its effectiveness and safety in treating moderate-to-severe atopic dermatitis, a common skin condition characterized by itchy and inflamed skin. This medication is in the clinical trial phase, meaning it is being tested in a controlled setting to gather more information about its benefits and potential side effects. The main goal of BP1.7881 is to help reduce the symptoms of atopic dermatitis by targeting specific pathways in the body that cause inflammation. It belongs to a class of drugs that work by modulating the immune system to decrease inflammation and improve skin health.

Investigated diseases

Atopic dermatitis – Atopic dermatitis is a chronic inflammatory skin condition characterized by dry, itchy, and red skin. It often begins in childhood but can occur at any age. The disease progresses through periods of flare-ups and remissions, where symptoms can worsen and then improve. During flare-ups, the skin may become more inflamed, leading to increased itching and discomfort. Over time, repeated scratching can cause the skin to thicken and become more susceptible to infections. The condition is associated with a compromised skin barrier and an overactive immune response.