A phase 2b, randomised, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered LEO 138559 in adult subjects with moderate-to-severe atopic dermatitis (AD)
This research study is looking into a new medicine called LEO 138559 for adults who have eczema that is moderate to severe. Eczema, also known as atopic dermatitis, can cause dry, itchy, and inflamed skin. The study aims to find out if this new medicine is safe and how well different doses work to improve eczema symptoms. Participants will receive either the study medicine or a dummy medicine (placebo) by injection under the skin. We will observe how their eczema changes over 16 weeks, specifically looking at the EASI score, which measures the severity and area of eczema. We will also monitor any side effects that might occur.
At a glance
What is this study about?
This study is called a 'Phase 2b' trial. This means it's an important step in developing new medicines. We're past the very early stages of testing and are now focusing on whether the medicine works well and how safe it is in a larger group of people with the condition.
Eczema, or atopic dermatitis, is a common skin condition that can be very uncomfortable. It causes the skin to become dry, red, itchy, and sometimes swollen. For some people, eczema can be moderate to severe, meaning it significantly affects their daily lives. This study is testing a new potential medicine, LEO 138559, to see if it can help improve these symptoms.
The main goal of this study is to see how much improvement there is in eczema symptoms after 16 weeks for people taking LEO 138559, compared to those taking a dummy medicine. We'll be using a special score called the EASI score, which helps doctors measure the severity and amount of eczema on the body. We'll also be carefully looking out for any side effects people might experience.
Key takeaways
- This study is testing a new medicine for moderate to severe eczema.
- It aims to find safe and effective doses of the medicine.
- Participants will receive either the new medicine or a dummy medicine.
- The study lasts 16 weeks with regular check-ups.
- Both men and women aged 18 and over with eczema can be considered.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have moderate to severe eczema. Both men and women are welcome to take part.
To be considered for the study, your eczema needs to be diagnosed as moderate to severe by a doctor. This means your eczema is likely causing you significant discomfort and might not be well-controlled with your current treatments.
There will be other detailed criteria that the study doctors will check to make sure the study is right for you and that you can participate safely. For example, they will need to check your general health and any other medications you are taking.
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 eczema (atopic dermatitis)?
- Has your doctor told you your eczema is moderate to severe?
- Are you able to attend appointments at a study clinic regularly for 16 weeks?
- Are you willing to receive injections under the skin?
What does participation involve?
If you decide to join this study, it will involve several visits to a clinic over a total of 16 weeks. You will be given either the new medicine, LEO 138559, or a dummy medicine (placebo) by an injection under your skin. Which one you receive is decided randomly, like flipping a coin, and neither you nor your study doctor will know which one it is (this is called 'double-blind').
Throughout the study, you'll have regular check-ups with the study team. These visits will include checks of your general health, blood tests, and assessments of your eczema symptoms, including taking your EASI score. It's important to attend all scheduled appointments so the researchers can accurately track your progress and safety. You'll also be asked to report any new symptoms or side effects you might experience.
Potential risks and benefits
Locations (7)
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedPoland
Common questions
What is a 'Phase 2b' trial?
It's a stage of medicine development where we test if a treatment works and is safe in a larger group of people, after earlier safety tests.
What is 'atopic dermatitis'?
It's the medical name for eczema, a common skin condition that causes dry, itchy, and irritated skin.
What does 'placebo-controlled' mean?
It means some people get the new medicine, and others get a 'dummy' medicine that looks the same but has no active ingredients. This helps us see if the new medicine really works.
What is an 'EASI score'?
It's a way doctors measure how severe your eczema is and how much of your body it covers. A lower score means less severe eczema.
How will I receive the study medicine?
The medicine will be given as an injection under your skin, similar to some diabetes or allergy treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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