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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study participation</b>

    Participation in the study begins with the administration of either the test medication, called bfb759, or a placebo, which is a substance with no active medicine.

    The bfb759 is given as a subcutaneous injection, which means the liquid is injected into the fatty layer of the skin just below the surface.

    The study is double-blind, meaning neither the person receiving the treatment nor the staff know whether the bfb759 or the placebo is being administered.

  2. Step 2

    <b>treatment phase</b>

    The treatment continues for a period of 16 weeks.

    During this time, the effectiveness of the medication is measured by looking at the number of abscesses (painful, swollen lumps filled with pus) and inflammatory nodules (painful lumps under the skin) caused by hidradenitis suppurativa.

  3. Step 3

    <b>evaluation of results</b>

    At week 16, the results are assessed by comparing the number of abscesses and nodules to the levels recorded at week 0.

    Changes in skin pain and the severity of skin symptoms are also recorded to determine how the body responds to the bfb759 or the placebo.

Who can join the trial?

7 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

  • Placebo

    This is an inactive substance that looks exactly like the actual medication but contains no active medicine. It is administered via subcutaneous injection to serve as a comparison group in the study to help researchers determine if the test drug truly works. It is not used to treat any medical conditions.

  • BFB759

    This medication is an experimental treatment administered through a subcutaneous injection under the skin. It is currently being studied in clinical trials and is not yet available as a standard medical treatment for patients. This drug is being tested to treat moderate to severe hidradenitis suppurativa, a skin condition that causes painful lumps and abscesses. It belongs to a class of drugs designed to work at a molecular level by targeting specific parts of the immune system to reduce inflammation and prevent the formation of skin lesions.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522440-41-00Protocol codeCL-BFB759-003Estimated enrolment210 patientsSponsorBluefin Biomedicine Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).