A study to evaluate the effectiveness and safety of BFB759 in adults with moderate to severe hidradenitis suppurativa

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What is this study about?

This study focuses on individuals living with Hidradenitis Suppurativa, a long-term skin condition that causes painful lumps under the skin. These lumps, known as abscesses or inflammatory nodules, often appear in areas where skin rubs together, such as the armpits or groin. The purpose of the study is to evaluate the efficacy and safety of a study drug called BFB759.

Participants in this research will be assigned to receive either BFB759 or a placebo through a subcutaneous injection, which is a shot given into the fatty layer of tissue just under the skin. This is a double-blind study, meaning that neither the participants nor the researchers will know which substance is being administered during the trial. The study is randomized, so the assignment of the treatment is decided by chance.

During the course of the study, the effects of the medication will be monitored over time. Researchers will look at changes in the number of skin lumps and track any adverse events, which are unexpected medical problems or side effects that may occur during treatment. The study will observe how the skin responds to the different doses of the medication compared to the placebo.

Who Can Join the Study?

  • You must be an adult, which means you are between 18 and 75 years old.
  • You must have been diagnosed with hidradenitis suppurativa, a skin condition that causes painful bumps and sores, for at least one year.
  • Your condition must be moderate to severe, meaning the symptoms are significant and affecting your life.
  • Your condition must not be well managed by systemic antibiotic treatment, which refers to medicine used to fight infections that works throughout your entire body.
  • You must be willing to follow all the instructions provided for the study.
  • You must be able to attend regularly scheduled visits.
  • You must agree to avoid certain other medications while participating in the study.

Who Cannot Join the Study?

  • Having specific types of infections, which are illnesses caused by harmful germs like bacteria or viruses, or other immune conditions, which are problems with the body’s natural defense system that fights off sickness.
  • Having recently taken certain medications, or medicines, that might change how the study drug works or interfere with the results.
  • Being pregnant, which means carrying a baby inside the body, or breastfeeding, which is providing milk from the breast to a baby.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Sanatorium profesora Arenbergera Prague Czechia
Dermedic Jacek Zdybski Ostrowiec Swietokrzyski Poland

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Josef-Hospital Bochum Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
CCR Ostrava s.r.o. Moravska Ostrava A Privoz Czechia
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital General De Granollers Granollers Spain
Renew Clinic Sp. z o.o. Bialystok Poland
Pratia Pardubice a.s. Pardubice Czechia
Melita Medical sp. z o.o. Wroclaw Poland
Medical Center Teodora EOOD Ruse Bulgaria
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Mjcchhibwly Utayp Sfb z ofll Warsaw Poland
Nlnf Sncfwfpr Oqfhilm Dloiyxujkbdnznl Dpxrsl Bialystok Poland
Lecytgt Shfobxjqyalhfjx Ggccyoy Dwwbtwlfznrfmtw Lublin Poland
Ganaqf Uhxsrcclmi Fhcwkujwu Frankfurt Germany
Krgydevl dow Unceghrtotey Mqbordtf Aen Munich Germany
Dntyxgwdox Ssg z ogvw Wroclaw Poland
Hrrttrdv Dy Ly Sfwbq Cdta I Sump Pdy Barcelona Spain
Munsvci Cnpqch Mriuvglqxy Pjbphz Okr Pleven Bulgaria
Mnqkhuv Czwxpg Mbzhgpuaiy &awftwq Bxdbyb 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
Recruiting
01.03.2026
Czechia Czechia
Recruiting
01.03.2026
Germany Germany
Recruiting
01.03.2026
Poland Poland
Recruiting
01.03.2026
Spain Spain
Not yet recruiting
01.03.2026

Trial locations

BFB759 is an experimental medication given as an injection under the skin. It is being studied to see if it can help reduce the number of painful bumps, such as abscesses and inflammatory nodules, in people living with moderate to severe hidradenitis suppurativa.

Hidradenitis suppurativa – This is a chronic skin condition that causes painful lumps to form under the skin. It typically occurs in areas where skin rubs together, such as the armpits or groin. The condition begins with the formation of inflammatory nodules and abscesses. Over time, these lumps may rupture and drain fluid, often leading to the development of tunnels or tracts under the skin. Persistent inflammation can also result in scarring and thickened skin in the affected areas.

Trial ID:
2025-522440-41-00
Protocol code:
CL-BFB759-003
Trial Phase:
Therapeutic exploratory (Phase II)

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