In short
There are currently 2 ongoing clinical trials investigating new treatments for pyoderma gangrenosum, a rare and painful skin condition characterized by ulcers. These studies are testing medications called spesolimab and vilobelimab, administered through infusion, to determine if they can help heal the ulcers and reduce pain. The trials are taking place across multiple European countries including Germany, France, Spain, Italy, Poland, Belgium, and others.
Clinical trial locations
- Austria
- Belgium
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Spain
- Sweden
Study on Spesolimab for Adults with Pyoderma Gangrenosum Requiring Systemic Therapy
This trial is testing a medication called spesolimab, which is given directly into the bloodstream through an intravenous infusion. The study compares spesolimab to a placebo to determine whether it can effectively help heal the painful ulcers caused by pyoderma gangrenosum.
Who can participate: To join this study, you must be at least 18 years old and have a confirmed diagnosis of ulcerative pyoderma gangrenosum that requires treatment affecting your whole body. You need to have at least one measurable ulcer that is at least 5 square centimeters in size. The ulcer should have been diagnosed within the last 6 months, or if it has been longer, it must still be active and getting worse. Women who can become pregnant must agree to use highly effective birth control methods during the study.
Who cannot participate: People who are outside the specified age range, have medical conditions other than pyoderma gangrenosum, are part of vulnerable populations requiring special care, or do not meet other specific health criteria required for the study cannot participate.
Study goals: The main goal of the trial is to achieve complete closure of the target ulcer by week 26, meaning the ulcer area is reduced by 100% and remains healed for at least two weeks. The study will run for up to 52 weeks with regular check-ups to monitor healing progress, pain levels, and any recurrence of ulcers. Researchers also want to measure whether spesolimab can reduce pain within 4 weeks and prevent ulcers from returning.
Investigational drug: Spesolimab is a monoclonal antibody that works by targeting and blocking specific proteins in the immune system that contribute to inflammation and tissue damage in the skin.
Study on Vilobelimab and Drug Combination for Treating Ulcerative Pyoderma Gangrenosum in Adults
This clinical trial is evaluating vilobelimab, a medication administered through intravenous infusion, for treating ulcerative pyoderma gangrenosum. Participants will receive either vilobelimab or a placebo, and the results will be compared to see how well vilobelimab works. The study also involves the use of other anti-inflammatory medications such as corticosteroids, including betamethasone, methylprednisolone, prednisone, and others.
Who can participate: You must be 18 years or older and have a confirmed diagnosis of ulcerative pyoderma gangrenosum with a PARACELSUS score of 10 points or more. This score helps measure the severity of your condition. You need to have at least one evaluable ulcer that is at least 5 square centimeters in area, surrounded by intact skin, and measurable in at least two directions. The ulcer should not be near a stoma.
Who cannot participate: People who have a different condition than ulcerative pyoderma gangrenosum, are not within the specified age range, are part of vulnerable populations, or do not meet the specific health requirements set by the study cannot participate.
Study goals: The primary goal is to achieve complete closure of the target ulcer, which means the ulcer is fully re-epithelialized without needing drainage or dressings, confirmed at two consecutive visits two weeks apart. Throughout the study, regular assessments will measure ulcer healing, pain reduction using a scale from 0 to 10, and overall improvement in the condition. Secondary goals include reducing pain and ulcer volume.
Investigational drug: Vilobelimab is a monoclonal antibody that inhibits a specific protein involved in the inflammatory process. By blocking this protein, vilobelimab helps decrease the immune response that causes tissue damage, potentially promoting healing of the ulcers.
Summary
Both ongoing clinical trials for pyoderma gangrenosum are focused on testing innovative treatments using monoclonal antibodies delivered through intravenous infusion. These medications, spesolimab and vilobelimab, work by targeting specific immune system proteins to reduce inflammation and promote healing of painful ulcers.
The trials share similar inclusion criteria, requiring participants to be adults with confirmed diagnoses and measurable ulcers of at least 5 square centimeters. Both studies aim to achieve complete ulcer closure as their primary goal, with secondary objectives including pain reduction and prevention of recurrence.
Geographically, both trials have a strong presence across Europe, with Germany, Belgium, France, Spain, Italy, and Poland participating in both studies. This wide distribution suggests a collaborative European approach to finding effective treatments for this rare and challenging skin condition. The spesolimab trial has a slightly broader geographic reach, including additional countries such as Austria, Finland, Norway, Portugal, and Sweden.
These trials represent important research efforts to find safe and effective treatments for people living with pyoderma gangrenosum, a condition that currently has limited treatment options and can significantly impact quality of life.
