Not recruitingRare disease

Study on Vilobelimab and Drug Combination for Treating Ulcerative Pyoderma Gangrenosum in Adults

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the treatment of ulcerative pyoderma gangrenosum, a rare skin condition that causes painful ulcers. The study will evaluate the effectiveness and safety of a medication called vilobelimab, which is administered as a solution for infusion. Participants in the trial will receive either vilobelimab or a placebo, which is a substance with no active medication, to compare the outcomes.

The purpose of the study is to determine how well vilobelimab works in treating ulcerative pyoderma gangrenosum. The trial will involve multiple visits over a period of time, where participants will receive the treatment and be monitored for any changes in their condition. The study will assess the healing of the ulcers, any reduction in pain, and overall improvement in the skin condition.

In addition to vilobelimab, the study will also involve the use of other medications such as betamethasone, methylprednisolone, prednisone, cortisone acetate, dexamethasone, hydrocortisone, prednisolone, triamcinolone, and fludrocortisone. These medications are glucocorticoids or corticosteroids, which are commonly used to reduce inflammation and suppress the immune system. The trial will help to understand the potential benefits and safety of vilobelimab in comparison to these other treatments.

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
Joining the study
Upon joining the study, the patient provides signed informed consent, confirming understanding and agreement to participate.
The patient must be 18 years or older and have a confirmed diagnosis of ulcerative pyoderma gangrenosum, with a PARACELSUS score of 10 points or more.
Step 2
Initial assessment
The patient undergoes an initial assessment to confirm the presence of at least one evaluable ulcer, which must be at least 5 cm² in area and surrounded by intact skin.
The ulcer is evaluated using two-dimensional measurements to establish a baseline for the study.
Step 3
Treatment phase
The patient receives treatment with either vilobelimab or a placebo. The specific dosage and frequency are determined by the study protocol.
The treatment aims to achieve complete closure of the target ulcer, defined as re-epithelization without drainage or dressing needs, confirmed at two consecutive visits two weeks apart.
Step 4
Ongoing assessments
Throughout the study, the patient attends regular visits for assessments of ulcer healing, pain levels, and any changes in condition.
Pain reduction is measured using a numeric rating scale from 0 to 10, with specific goals for reduction set at various points in the study.
Step 5
End of treatment evaluation
At the end of the treatment phase, the patient undergoes a final evaluation to assess the overall effectiveness of the treatment.
The primary goal is the complete closure of the target ulcer, while secondary goals include pain reduction and ulcer volume reduction.

Who can join the trial?

6 criteria

You must sign a form that shows you understand the study and agree to take part.
You need to be **18 years or older** when you sign the form.
A doctor must confirm that you have a condition called **ulcerative pyoderma gangrenosum (PG)**. This is a skin condition, and the diagnosis should be supported by a special score called the **PARACELSUS score**, which should be **10 points or more**.
You must have at least one **PG ulcer** (a type of sore) that can be evaluated. This ulcer should not be near a stoma (an opening on the body). The ulcer must meet these criteria:
- The area of the ulcer should be **5 square centimeters or larger** at the start of the study.
- The ulcer should be surrounded by skin that is not damaged.
- The ulcer should be measurable in at least two directions.

Who cannot join the trial?

4 criteria

Patients who have a different condition than ulcerative pyoderma gangrenosum cannot participate. This is a specific skin condition that causes painful sores.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health requirements set by the study cannot participate. These requirements ensure the safety and relevance of the study for participants.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands
Hospices Civils De Lyon
Responsive
Lyon, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Vilobelimab is a medication being studied for its effectiveness in treating ulcerative pyoderma gangrenosum, a rare skin condition that causes painful ulcers. The trial aims to determine how well vilobelimab works in reducing the symptoms and improving the healing of these ulcers.

What is already known about the treatment

Vilobelimab – Vilobelimab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials, specifically in a Phase III trial, to assess its effectiveness and safety for treating ulcerative pyoderma gangrenosum, a rare skin condition. The main therapeutic indication for vilobelimab is to reduce inflammation and promote healing in patients with this condition. At the molecular level, vilobelimab works by inhibiting a specific protein involved in the inflammatory process, which helps to decrease the immune response that causes tissue damage. It is classified pharmacologically as a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

Investigated diseases

Ulcerative Pyoderma Gangrenosum – This is a rare inflammatory skin condition characterized by painful ulcers, typically on the legs. It begins as a small pustule or nodule that rapidly breaks down to form a larger ulcer. The edges of the ulcer are often undermined and the surrounding skin may be red and swollen. The condition can progress with the development of new ulcers or the enlargement of existing ones. It is often associated with systemic diseases such as inflammatory bowel disease or arthritis. The exact cause is unknown, but it is believed to involve an abnormal immune response.