A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis.
This research study is looking at a new medicine called amlitelimab for people aged 12 and older who have moderate to severe eczema (atopic dermatitis). Eczema can be very uncomfortable, causing red, itchy, and inflamed skin. The study wants to find out if amlitelimab is safe and effective in improving these symptoms. Participants will receive either the new medicine, an existing treatment, or a placebo (a dummy medicine with no active ingredients). Doctors will be closely monitoring how participants' eczema changes, using special scores to measure improvements in skin condition and itching. This information will help decide if amlitelimab could be a helpful new treatment option.
At a glance
What is this study about?
This study is a clinical trial, which means it's testing a new medicine in people to see if it works and is safe. The medicine is called amlitelimab, and it's being investigated as a treatment for moderate-to-severe atopic dermatitis, which is the medical term for eczema. If you have eczema, you'll know it can cause very itchy, red, dry, and sometimes cracked skin. The study is running in several countries, including those in Europe and Japan, and is looking for participants aged 12 and older.
The main goal of the study is to see if amlitelimab can help improve eczema symptoms. Researchers will look at how many participants achieve clear or almost clear skin and how much their itching is reduced. They will be comparing amlitelimab to a 'placebo', which is a dummy treatment without any active medicine. This helps them understand if any improvements are genuinely due to the new medicine or not. Sometimes, existing medicines like pimecrolimus or tacrolimus are also used for comparison.
This is a 'Phase 3' study, which means the medicine has already been through earlier tests and shown some promise. It's normally the last step before a medicine might be made available to everyone. By taking part, healthy volunteers are helping doctors understand the medication better and potentially bring a new treatment option to people living with eczema.
Key takeaways
- Testing a new medicine (amlitelimab) for moderate-to-severe eczema.
- Compares amlitelimab to existing treatments or a dummy medicine (placebo).
- Focuses on people aged 18 and older.
- Aims to improve skin clearing and reduce itching.
- Participation involves regular clinic visits and possibly self-injections.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you generally need to be at least 18 years old. The study is open to both men and women.
Beyond age and sex, specific details about your health and your eczema will be checked by the study doctors. For example, they will need to confirm that your eczema is considered 'moderate-to-severe'. Your overall health will also be important to make sure it's safe for you to take part.
It's important to remember that these are just general guidelines. The study team will review your full medical history to see if you meet all the requirements. They will explain everything clearly if you are interested in learning more.
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.
- Am I at least 18 years old?
- Do I have moderate-to-severe eczema (atopic dermatitis)?
- Am I generally in good health?
- Am I able to attend regular clinic appointments?
What does participation involve?
If you join this study, you would first have a screening visit to check if it's right for you. If you qualify, you'd be randomly assigned to one of three groups: you'd get the new medicine (amlitelimab), an existing eczema treatment (like pimecrolimus or tacrolimus), or a placebo (a dummy medicine).
The amlitelimab will be given as an injection under the skin, which you or a study nurse might administer. You'd have regular visits to the clinic, where doctors and nurses would check your skin, measure your eczema symptoms, and ask about your itching and how your eczema affects your daily life. They will also take blood samples and perform other health checks to monitor your safety. The study will last for a specific period, and regular follow-up will be involved to track your progress and any effects of the medicine.
Potential risks and benefits
Locations (7)
- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedBulgaria
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedDenmark
- —UnverifiedSweden
Common questions
What is eczema (atopic dermatitis)?
Eczema is a common skin condition that makes your skin red, itchy, and dry. It often comes and goes, and can be uncomfortable.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine is actually working.
What does 'subcutaneous injection' mean?
It means the medicine is given by a small injection just under the skin, like an insulin shot.
Will I know if I'm getting the new medicine or the placebo?
No, in this study, neither you nor the study doctors will know which treatment you are receiving until the study is over. This is called 'double-blind' and helps keep the results fair.
How long will this study last?
The study has specific timeframes for checking how the medicine works, like at Week 24. The full length of your participation would be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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