Not recruiting

A study testing BFB759 compared to placebo to evaluate effectiveness and safety in adult patients with atopic dermatitis

Fast replyInvestigationalNo placebo

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What is this trial about?

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

This study involves atopic dermatitis, a long-term skin condition that causes red, itchy, and inflamed skin. The treatment being tested is called BFB759, which is given as an injection under the skin. Some people in the study will receive BFB759 while others will receive placebo. The purpose of this study is to evaluate how well BFB759 works in adults with atopic dermatitis and to check if it is safe to use.

The study is designed for adults between 18 and 75 years old who have had atopic dermatitis for at least one year and whose condition is moderate to severe and not well controlled by creams or ointments applied to the skin. Participants will be randomly assigned to receive either BFB759 or placebo for a treatment period of 14 weeks. During the study, participants will need to attend regular visits and avoid using certain other medications.

The main goal is to measure changes in the severity and extent of skin symptoms using a scoring system that looks at redness, thickness, scratching marks, and the area of skin affected. The study will also track how many people experience significant improvement in their symptoms, changes in the amount of body surface area affected by the condition, overall disease severity scores, and improvements in itching. The safety of the treatment will be monitored by recording any unwanted side effects that occur during the study.

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
Treatment period begins
After joining the study, you will be randomly assigned to one of three groups. You may receive either BFB759 at one of two different dose levels, or placebo. Placebo is an inactive substance that looks like the actual medication but contains no active ingredient.
The medication will be administered as a subcutaneous injection, which means it will be injected under the skin.
This is a double-blind study, meaning neither you nor the study staff will know which treatment you are receiving during the trial.
Step 2
Regular study visits and assessments
You will attend regular study visits throughout the treatment period.
During these visits, your skin condition will be assessed using several measurement tools to track changes in your atopic dermatitis.
The assessments will include measuring the extent and severity of your skin condition, the amount of body surface area affected, and the intensity of itching you experience.
Safety monitoring will occur at each visit to check for any side effects or adverse events.
Step 3
Week 16 assessment
At Week 16, a comprehensive evaluation of your condition will be performed.
The study team will measure the percentage change in your EASI score, which stands for Eczema Area and Severity Index. This score measures both how much of your body is affected by atopic dermatitis and how severe the symptoms are.
Additional measurements will be taken to evaluate the overall improvement in your skin condition, including body surface area affected and overall disease severity.
Your itch level will be assessed using a numerical rating scale, where you rate the intensity of itching.
Step 4
Ongoing treatment and monitoring
Throughout the study, you will need to follow specific instructions regarding other medications. Certain treatments will need to be avoided during the trial period.
You will continue to receive the assigned treatment according to the study schedule.
Any side effects or health changes should be reported during your scheduled visits.
Step 5
Study completion
The study will continue until the scheduled end date.
Final assessments will be completed to evaluate the overall safety and effectiveness of the treatment you received.
All safety information, including any adverse events experienced during the study, will be documented using standardized medical criteria.

Who can join the trial?

7 criteria

You must be between 18 and 75 years old
You must have been diagnosed with atopic dermatitis, which is a skin condition that causes red, itchy, and inflamed skin, for at least one year
Your atopic dermatitis must be moderate to severe, meaning your symptoms are not mild
Your condition must not be well controlled by topical treatments, which are creams, ointments, or lotions applied directly to the skin
You must be willing to follow all instructions given during the study
You must be able to attend all scheduled visits regularly throughout the study
You must be willing to avoid using certain other medications during the study period

Who cannot join the trial?

4 criteria

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this data
Generally, clinical trials have rules about who can join to ensure the safety of participants and the accuracy of results
Common reasons people might not be able to join studies include having other serious health conditions, taking certain medications, being pregnant or breastfeeding (feeding a baby with milk from the breast), or having allergies to the study medication
The study doctor will review your complete health history to determine if you are able to participate safely

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Verified sites

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

Verified
CRS Clinical Research Services Management GmbH
Berlin, Germany
Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Synexus Polska Sp. z o.o.
Poznan, Poland

Trial locations

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Investigated drugs

BFB759
is an investigational medication being studied for the treatment of atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. This medication is being tested to see if it can help reduce the symptoms of atopic dermatitis in adults.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against the investigational medication to help determine if the medication is truly effective.

What is already known about the treatment

BFB759 – BFB759 is an investigational medication currently being studied in clinical trials for the treatment of atopic dermatitis, a chronic skin condition that causes red, itchy, and inflamed skin. The drug is being tested in a Phase 2 trial to determine the most effective dose and to evaluate how well it works in reducing the symptoms of atopic dermatitis, as measured by improvements in skin rash severity and affected body surface area. At this stage, BFB759 is not yet approved for general medical use and is only available to participants enrolled in research studies. The specific form of administration, exact mechanism of action, and pharmacological classification have not been disclosed in the available trial information.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis is a chronic inflammatory skin condition that causes the skin to become red, itchy, and dry. The disease typically appears in childhood but can occur at any age, affecting both males and females. It is characterized by periods of flare-ups when symptoms worsen, followed by periods of improvement. The affected skin areas often include the face, hands, feet, inner elbows, and behind the knees. During flare-ups, the skin may develop patches that are intensely itchy, leading to scratching that can further damage the skin. The condition is related to how the immune system responds and problems with the skin barrier that normally protects against irritants and allergens.