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Study on Spesolimab for Adults with Pyoderma Gangrenosum Requiring Systemic Therapy

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What is this trial about?

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

This clinical trial is focused on a skin condition called pyoderma gangrenosum, which is characterized by painful ulcers. The study is testing a treatment called spesolimab, also known by its code name BI 655130. Spesolimab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of spesolimab to a placebo, which is a substance with no active medication, to see if spesolimab is more effective in treating this condition.

The purpose of the study is to determine if spesolimab can help achieve complete healing of the ulcers caused by pyoderma gangrenosum. Participants in the study will receive either spesolimab or a placebo and will be monitored over a period of time to see if their ulcers heal completely. The study will last up to 52 weeks, with the main focus on the first 26 weeks to see if the ulcers close completely and remain healed for at least two weeks.

Throughout the study, participants will have regular check-ups to monitor their progress. The study aims to provide valuable information on whether spesolimab can be a safe and effective treatment option for people suffering from pyoderma gangrenosum. The ultimate goal is to find a treatment that can help reduce the area of the ulcers and improve the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of the medication spesolimab or a placebo. The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

    The goal of this phase is to evaluate the safety and effectiveness of spesolimab in treating the skin condition known as pyoderma gangrenosum.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the progress of the treatment. This includes checking the size and condition of the skin ulcers.

    The primary aim is to achieve complete closure of the target ulcer, which means a 100% reduction in the ulcer area, by Week 26.

  3. Step 3

    Follow-up visits

    Follow-up visits are scheduled to confirm the closure of the ulcer. These visits occur at least two weeks after the initial observation of complete closure.

    Additional assessments may include measuring pain levels and checking for any recurrence of the ulcers.

  4. Step 4

    Secondary outcomes

    Secondary outcomes include achieving complete closure of any measurable ulcer at any time up to Week 26, and a reduction in pain scores by Week 4.

    The time to recurrence of the ulcers is also monitored up to Week 52 for those who achieved complete closure by Week 26.

Who can join the trial?

6 criteria

  • You must be an adult, which means you need to be at least 18 years old. If the age of consent is different where you live, those rules will be followed.
  • You need to sign a written consent form, which means you agree to participate in the study and understand what it involves.
  • You must have a confirmed diagnosis of **ulcerative pyoderma gangrenosum**. This is a skin condition that causes painful sores. Your condition should require treatment that affects your whole body, not just the skin. The diagnosis will be confirmed by a special committee.
  • You need to have at least one sore from pyoderma gangrenosum that is measurable, meaning it is at least 5 square centimeters in size. If you have more than one sore, the main one will be chosen by the study doctor and confirmed by a committee.
  • The sore you have should have been diagnosed within the last 6 months. If it has been longer than 6 months, the sore must still be active and getting worse, as judged by the study doctor and confirmed by a committee.
  • If you are a woman who can have children, you must be willing and able to use very effective birth control methods. These methods should have a very low chance of failing if used correctly.

Who cannot join the trial?

4 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions other than Pyoderma gangrenosum, which is a rare skin condition that causes painful ulcers.
  • Patients who are part of a vulnerable population, meaning they may need special protection or care.
  • Patients who do not meet other specific health criteria required for the study.
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Investigated drugs

Spesolimab is a medication being studied for its potential to help patients with ulcerative pyoderma gangrenosum, a condition that causes painful skin ulcers. The trial aims to see if spesolimab can effectively close these ulcers completely, improving the patient's condition.

What is already known about the treatment

Spesolimab – This medication is administered through an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating ulcerative pyoderma gangrenosum, a rare skin condition. Spesolimab works by targeting and blocking specific proteins in the immune system that contribute to inflammation and tissue damage. It is classified as a monoclonal antibody, which is a type of drug designed to interact with specific molecules in the body.

Investigated diseases

Pyoderma gangrenosum – Pyoderma gangrenosum is a rare skin condition characterized by the rapid development of painful ulcers. It often begins as small, red bumps that quickly progress to open sores with a purplish border. The ulcers can vary in size and may merge to form larger areas of skin damage. This condition is often associated with systemic diseases like inflammatory bowel disease or arthritis. The exact cause is not well understood, but it is believed to involve an abnormal immune response. The progression of the disease can be unpredictable, with periods of healing and flare-ups.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514306-31-00Protocol code1368-0140Estimated enrolment89 patientsSponsorLeo Pharma A/S

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