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

2 1

What is this study about?

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.

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.

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.

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).

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Klinika Ambroziak Sp. z o.o.	Warsaw	Poland
Hopital Tenon	Paris	France
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Clinical Research Group Sp. z o.o.	Warsaw	Poland
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
TFS Trial Form Support GmbH	Hamburg	Germany
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Csvnqik Bfrzv Klcizjeszka Prgvnpdm Suc z ourk	Gdansk	Poland
Cvipjlm dz Dhppcwmfbban &xokupc Mneosdtdh	Martigues	France
Lhitban Skjs Bywty Biwklasmqogdh Banjgyr Sgkzkfjltawe	Ossy	Poland
Niaw Svvwfevq Oqqfeod Deljlltpjamozad Dvhowg	Bialystok	Poland
Gnrqqr Uqhlmwmymr Fdaeyiwcr	Frankfurt	Germany
Pssyrtv Sxr z opxq	Katowice	Poland

Trial status

Country	Status	Recruitment Start
France	Not recruiting	20.06.2023
Germany	Not recruiting	20.06.2023
Poland	Not recruiting	20.06.2023

Trial locations

Investigated drugs:

Bp1.7881A

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.

Investigated diseases:

Dermatitis atopic

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.

Trial ID:

2022-502045-10-00

Protocol code:

P20-03

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?