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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ICMR (International Center for Medical Research) Madrid Spain
Universitaetsmedizin Goettingen Goettingen Germany
Hospital Clinico San Carlos Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland

Other Sites

Site Name City Country Status
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Clinicmed Daniluk Nowak Sp. k. Bialystok Poland
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
Hospital General De Granollers Granollers Spain
Asclepius Medical Center OOD Dupnitsa Bulgaria
Renew Clinic Sp. z o.o. Bialystok Poland
Pratia Pardubice a.s. Pardubice Czechia
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Grodzisk Mazowiecki Poland
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Clintrial s.r.o. Prague Czechia
CRS Clinical Research Services Management GmbH Berlin Germany
Synexus Polska Sp. z o.o. Poznan Poland
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
EMC Instytut Medyczny S.A. Poznan Poland
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska Chorzow Poland
Prywatna Praktyka Lekarska Ewa Ring Warsaw Poland
Tpvatbrx Nduq Szk z ofmi Warsaw Poland
Uvdunxjkdvoriptebvula Ejolz Alp Essen Germany
Cqxksil Bjnwd Kffgakgshcg Poywxrjs Stc z oahe Gdansk Poland
Txmpwlmcgym uck Spimhfbvbxa Bjbgghru Gkyu Bad Bentheim Germany
Mgpvluhonoe Ukjyw Slh z oxzs Warsaw Poland
Mfamadzfu Izcgmfnepg Cmyvjpon Syptftfp Sst z ozwf Warsaw Poland
Ursvobcuvvpxmlsfrpwrg Mexxjevv Azb Munster Germany
Mhllzfc Csuvix Mvhfxszdyv Ptyvhy Ooz Pleven Bulgaria
Djivzygjsbejfsxjohfn ojrqrhul Msafo Bwzgca Hutsajzilec Pqqg Prague Czechia
Mkxngoo Ccqkxf Mkclyinikd &ahslop Bdyoft Burgas Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.11.2025
Czechia Czechia
Not recruiting
01.11.2025
Germany Germany
Not recruiting
01.11.2025
Poland Poland
Not recruiting
01.11.2025
Spain Spain
Not recruiting
01.11.2025

Trial locations

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.

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.

Trial ID:
2025-521624-30-00
Protocol code:
CL-BFB759-002
Trial Phase:
Therapeutic exploratory (Phase II)

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