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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany
Hospital Universitario De Salamanca Salamanca Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Hospices Civils De Lyon Lyon France
University Of Pecs Pecs Hungary
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Universita’ Di Pisa Pisa Italy
Centre Hospitalier Universitaire De Nantes Nantes France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
St. Josef-Hospital Bochum Germany
Staedtisches Klinikum Dessau Dessau-Roßlau Germany
Charite Research Organisation GmbH Berlin Germany
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Hospital Universitario Infanta Leonor Madrid Spain
University Of Szeged Szeged Hungary
Pcdzzltqd Izrrbmef Mdalxall Mhwmautqhppf Sqrdj Wdkznwhhnswg I Avtndzjvinzbs Warsaw Poland
Mcjlrui Sjwvncl Zkwkzupyx w Opfsjsrvj Olsztyn Poland
Cieldsbdd Umcjngrlhkjabj Sooiaukrd Woluwe-Saint-Lambert Belgium
Aumcvueega Prtwgxte Hsvoohad Dy Pwcfa Paris France
Uqtclgqubjnqdkjvftnta Dcoddqhqstb Amu Duesseldorf Germany
Eowagxb Uwvvsidqbcoy Mazcqdn Curdpuv Rqnrerwtx (dglrlfp Mjq Rotterdam The Netherlands
Lxrees Mwrjyklfbv Ussbiqvvnd Og Mookon Munich Germany
Aprvurz Oonlcchnhev Uunqxmdkwpagz Czhjivoswuwg Dhdma Sbdygb E Dagxf Szbpith Do Tknvpu Turin Italy
Gsjhfa Uutzonsbdh Fmloleekh Frankfurt Germany
Udcvwjnunryxwkrgxkksl Wmbhclhxi Ayw Wuerzburg Germany
Applazc Urrjz Sqcooqxia Lpefdm Df Bkwhpsc Bologna Italy
Urychyapmi Mcqztzf Cvwwhe Hmpzdnhabcnkdlgye Hamburg Germany
Ufkxbqcbubovrfyuqecyk Efnkl Aav Essen Germany
Mhqrhglzramumhivtvwzukvivd Hmohbxclnxulzczt Halle (Saale) Germany

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
03.11.2023
France France
Not recruiting
03.11.2023
Germany Germany
Not recruiting
03.11.2023
Hungary Hungary
Not recruiting
03.11.2023
Italy Italy
Not recruiting
03.11.2023
Poland Poland
Not recruiting
03.11.2023
Spain Spain
Not recruiting
03.11.2023
The Netherlands The Netherlands
Not recruiting
03.11.2023

Trial locations

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.

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.

Trial ID:
2023-506250-20-00
Protocol code:
IFX-1-P3.4
NCT ID:
NCT05964413
Trial Phase:
Therapeutic confirmatory (Phase III)

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