New therapeutic approach to Toxic Epidermal Necrolysis (TEN) using anti-CD38+ antibodies in the active phase of the disease – Phase I/II study to assess the tolerance and efficacy of DARATUMUMAB - NET-CD38 Study
This research study, called the NET-CD38 Study, is looking at a new way to treat a very serious skin condition known as Toxic Epidermal Necrolysis (TEN). TEN causes widespread blistering and skin peeling, which can be life-threatening. The study is testing a medicine called daratumumab, which targets specific cells in the body. Researchers want to find out if this medicine is safe to use and if it can help improve the condition and recovery for people who are in the active, early stages of TEN. This is an early-stage study (Phase I/II), meaning it's one of the first times this treatment is being tried in people with TEN, so we're primarily focused on safety and getting an early idea of how well it works. It's open to all adults aged 18 and over.
At a glance
What is this study about?
This study is exploring a new treatment for a very serious skin condition called Toxic Epidermal Necrolysis, often shortened to TEN. TEN is a rare but severe reaction, usually to a medicine, where large areas of your skin blister and peel away, much like a severe burn. This can be very dangerous and requires urgent medical care.
The research is testing a specific medicine called daratumumab. This medicine works by targeting certain cells in the body that have a marker on them called CD38. The idea is that by targeting these cells, daratumumab might help calm down the severe reaction that causes TEN and help the skin heal better. Researchers want to see if this new approach is safe and whether it can make a real difference for people who are currently going through the active, early stages of this difficult condition.
This is a 'Phase I/II' study, which means it's an early step in testing a new treatment. The main goals are to make sure the treatment is safe for people to use and to get an early understanding of how well it might work. This kind of research is crucial for finding better treatments for conditions like TEN in the future. By taking part, people could help doctors learn more and potentially improve care for others.
Key takeaways
- This study tests a new medicine (daratumumab) for severe skin condition (TEN).
- It's an early-stage study, checking safety and if it helps people in active TEN.
- Open to adults aged 18 and over, both men and women.
- Participation involves receiving the new medicine and regular check-ups.
- Potential benefits might include improved recovery from TEN.
- Potential risks include side effects from the new medicine.
Who may be eligible?
This study is looking for adults aged 18 and older. It's open to both men and women.
To join, you must currently be experiencing the active, early stages of Toxic Epidermal Necrolysis. This means you would need to have received a diagnosis of TEN recently.
There will be other detailed health requirements, probably related to your overall health and any other medications you are taking, to make sure this study is safe for you. Your doctor or the study team will be able to explain all these specific requirements.
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?
- Have you recently been diagnosed with Toxic Epidermal Necrolysis (TEN)?
- Are you currently experiencing the active, early stage of TEN?
- Are you able to attend regular hospital/clinic visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you'll be given the new medicine, daratumumab. The study team will regularly check how you're feeling and how your skin is responding to the treatment. This will involve regular visits to the hospital or clinic, where doctors will perform medical exams, take blood samples, and closely monitor your condition. They might also ask you questions about your symptoms and any side effects you might experience.
The exact number of visits, tests, and the total duration of your participation will be explained in detail by the study team. This will depend on the phase of the study you're in and how your treatment progresses. You'll have follow-up appointments even after you stop receiving the medication to ensure everything is well and to track your recovery over time.
Potential risks and benefits
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Common questions
What is Toxic Epidermal Necrolysis (TEN)?
TEN is a very severe skin reaction, often to a medicine, where your skin blisters and peels off, like a serious burn. It needs urgent medical attention.
What is daratumumab?
Daratumumab is a medicine being tested in this study. It works by targeting specific cells in the body, which researchers hope will help treat TEN.
Why is this study being done?
This study aims to find out if daratumumab is a safe and effective new treatment for people with TEN in the early stages of the disease.
Will I get the actual medicine or a dummy treatment?
Because this is an early-stage study focusing on a new treatment for a serious condition, it's likely that everyone in this particular study will receive the active medicine, daratumumab, rather than a dummy treatment (placebo). The study team will confirm which treatment you would receive.
How long will I be in the study?
The exact length of time will be explained by the study team, but it will involve receiving treatment and then follow-up appointments to monitor your progress.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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