A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated with Dupilumab.
This study is looking into a new medicine called eblasakimab for adults with moderate to severe eczema, also known as atopic dermatitis. These are people whose eczema hasn't fully improved with a previous treatment called dupilumab. The main goal is to check how well eblasakimab works to clear up their skin and to make sure it's safe to use. Some participants will receive eblasakimab, and others will receive a 'dummy' treatment (placebo) that looks exactly the same, but contains no active medicine. This helps researchers fairly compare the new medicine's effects. Everyone involved will receive regular injections under the skin and be monitored closely.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment, eblasakimab, for moderate to severe atopic dermatitis. Atopic dermatitis, commonly known as eczema, is a skin condition that causes dry, itchy, and inflamed skin. Moderate to severe means the eczema covers a significant area of the body, or is very bothersome and impacts daily life, and has not responded well to standard treatments.
The study is focusing on people who have already tried another common medicine for eczema called dupilumab, but whose skin condition still needs further improvement. The main aim is to understand if eblasakimab can effectively reduce eczema symptoms, such as redness and itching, and if it's safe for patients to use. By comparing eblasakimab with a placebo (a 'dummy' treatment that looks identical but contains no medicine), researchers can accurately tell what improvements are due to the new drug.
This kind of study, called a Phase 2 trial, is an important step in developing new medicines. It helps researchers gather more information about how the drug works, its best dose, and any potential side effects, before it can be considered for wider use. The results will help determine if eblasakimab is a promising new option for people living with challenging eczema.
Key takeaways
- Tests a new medicine (eblasakimab) for moderate to severe eczema.
- For adults who have previously tried Dupilumab.
- Compares eblasakimab to a placebo (dummy treatment).
- Involves regular injections and clinic visits for 16 weeks.
- Aims to check skin improvement and safety of the new medicine.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part in this research.
Crucially, you must have been diagnosed with moderate to severe atopic dermatitis, which is a type of eczema. This means your eczema is quite widespread or causes a lot of discomfort. You also need to have tried a specific treatment for your eczema called dupilumab in the past.
There might be other health conditions or medicines that would prevent you from joining the study, but the healthcare team will check all of this carefully with you to make sure it's safe and appropriate for you to participate.
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 a diagnosis of moderate to severe eczema (atopic dermatitis)?
- Have you previously used the eczema medicine called dupilumab?
- Are you able to attend regular clinic visits and receive injections?
What does participation involve?
If you join the study, you will receive regular injections under your skin. Some people will get the new medicine, eblasakimab, while others will get a placebo (a 'dummy' injection with no active medicine), but neither you nor your study doctor will know which you are receiving. This is to ensure fair results. The main part of the study will last for 16 weeks, during which you'll have several visits to the clinic.
During these visits, the study team will carry out various checks. They will look at your skin to assess your eczema severity, ask you questions about your itching and how your eczema affects your daily life, and measure your overall health. You will also have blood tests, vital sign checks (like blood pressure), and heart tracings (ECGs) to monitor your safety. After the initial 16 weeks, there may be longer-term follow-up visits to continue monitoring your health and any effects of the treatment.
Potential risks and benefits
Locations (2)
- —UnverifiedPoland
- —UnverifiedGermany
Common questions
What is eblasakimab?
Eblasakimab is a new medicine being tested to treat moderate to severe eczema (atopic dermatitis).
What is a 'placebo'?
A placebo is a 'dummy' injection that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
How long will I be in the study?
The main part of the study will last for 16 weeks, with potential for longer-term follow-up.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know this until the study is over. This is called 'double-blind' and ensures the results are as unbiased as possible.
What is 'atopic dermatitis'?
Atopic dermatitis is the medical term for a common type of eczema, which causes dry, itchy, and irritated skin.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.