A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, ADAPTIVE PHASE III TRIAL TO INVESTIGATE EFFICACY AND SAFETY OF VILOBELIMAB IN THE TREATMENT OF ULCERATIVE PYODERMA GANGRENOSUM
This research study is investigating a new medication called Gohibic for adults suffering from ulcerative pyoderma gangrenosum, a condition that causes painful skin ulcers. The study aims to find out if Gohibic is effective and safe in helping these ulcers heal faster and reducing the associated pain. Participants will receive either Gohibic, an existing treatment like prednisone, or a placebo (a dummy medicine with no active drug), without knowing which they are getting. Doctors will carefully monitor the healing of the ulcers, changes in pain levels, and any side effects. This type of study, known as a Phase III trial, is a crucial step in determining if new medicines can be approved for wider use to help patients.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research project to test new medications or treatments. Here, we're looking at a new medicine called Gohibic for people who have a skin condition called ulcerative pyoderma gangrenosum. This condition causes painful, open sores or ulcers on the skin, and finding effective treatments is very important.
The main goal of this study is to see if Gohibic can help these ulcers heal completely. Doctors will be tracking how many patients' ulcers fully close up, meaning the skin regenerates or scars over without any fluid leaking or needing dressings. They'll also be looking at other important things, like if the medicine reduces pain, how much the ulcers shrink, and if it leads to complete healing of all ulcers. The study will also carefully monitor any side effects to make sure the treatment is safe.
To make sure the results are fair and reliable, this study is designed in a way that neither the patients nor their doctors know whether they are receiving Gohibic, another existing treatment (like different types of cortisone medicines), or a placebo. A placebo looks just like the real medicine but contains no active drug. This helps researchers understand the true effect of Gohibic.
Key takeaways
- Tests a new medicine (Gohibic) for painful skin ulcers.
- Compares Gohibic to existing treatments and a dummy medicine.
- Aims to see if ulcers heal better and pain is reduced.
- Neither patients nor doctors know who gets which treatment.
- Careful monitoring of safety and progress throughout.
- Could lead to new treatment options for this condition.
Who may be eligible?
To be able to join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria.
Both men and women are invited to take part in this research. The study needs a diverse group of people to get a full understanding of how the new medicine works.
More specific details about your health condition, such as the type and severity of your ulcerative pyoderma gangrenosum, will be discussed by the study team. They will check your medical history to ensure the study is suitable and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have ulcerative pyoderma gangrenosum?
- Are you comfortable with regular hospital visits for assessments?
- Are you willing to potentially receive a placebo (dummy medicine)?
What does participation involve?
If you decide to take part in this study, you would be closely monitored by a team of healthcare professionals. You would have regular appointments at the study clinic. At these visits, doctors and nurses will assess your ulcers, take photographs to track their healing, and ask you about your pain levels. You will receive the study medication (Gohibic, a known treatment, or a placebo) throughout the trial.
These visits will also involve checks on your general health, such as blood tests, to make sure the treatment is safe for you. The study involves a period of taking the medication and then follow-up appointments to monitor your progress even after you stop taking the treatment. The total duration of your involvement, including all visits and follow-up, would be fully explained to you before you agree to participate.
Potential risks and benefits
Locations (8)
- —UnverifiedBelgium
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedNetherlands
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedItaly
Common questions
What is ulcerative pyoderma gangrenosum?
It's a rare skin condition that causes painful, open sores or ulcers on the skin, often on the legs, but can appear anywhere.
What is a 'double-blind' study?
It means that neither you nor your doctor will know if you are receiving the new medicine, an existing treatment, or a placebo (dummy medicine). This helps make the study fair.
What is a 'placebo'?
A placebo is a substance that looks just like the study medicine but doesn't contain any active drug. It's used to compare the real medicine's effects.
Why is this study important?
This study aims to find out if Gohibic can be a safe and effective new treatment to help heal painful ulcers caused by ulcerative pyoderma gangrenosum and improve patients' lives.
Will I still receive care if I don't join the study or leave early?
Yes, absolutely. Your decision to participate, or not, or to withdraw from the study, will not affect the quality of your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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